KR20230012512A - Device and method for supporting and positioning an intraocular lens within the eye - Google Patents

Abstract

An implantable device for supporting an intraocular lens within an eye includes a lens support structure having a central aperture; and one or more fixation arms coupled to the lens support structure and configured to position and stabilize the device within the eye. Related tools, systems and methods are provided.

Description

Device and method for supporting and positioning an intraocular lens within the eye

CROSS REFERENCES TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. Patent Application Serial No. 16/988,519, filed on August 7, 2020, and is also a continuation of co-pending U.S. Provisional Patent Application Nos. 63/017,423, filed on April 29, 2020; and 35 U.S.C. on co-pending U.S. Provisional Patent Application Serial No. 63/053,450, filed July 17, 2020; Claim the benefit of priority under §119(e). The disclosure of this application is incorporated by reference in its entirety.

The present disclosure relates generally to the field of ophthalmology, and more particularly to ophthalmic devices for supporting and positioning intraocular lenses within the eye.

Implantation of an intraocular lens (IOL) requires a support within the eye to hold the intraocular lens in the correct position. Generally, this is accomplished through the natural capsular bag suspended by zonules (thin-like structures). However, these supporting structures can be damaged due to endogenous factors such as pseudoexfoliation syndrome, Marfan syndrome, or Weill-Marchesani syndrome, or exogenous factors such as trauma. Additionally, the lens support may be iatrogenically altered during surgery (anterior segment or posterior segment surgery) or as a late complication of previous surgery, e.g., by capsular phimosis. ) may be damaged.

Management of secondary IOL placement in cases where capsular or zonal support is not sufficient continues to evolve. Currently, the only FDA-approved solution is the placement of an anterior chamber IOL (ACIOL). ACIOLs are larger lenses with the ability to position the anterior part of the iris, but over time these lenses cause endothelial cell loss and corneal decompensation as well as Uveitis-Glaucoma-Hyphema (UGH) syndrome. and, as a result, its use is contraindicated for many patients. A modified capsular tension ring (Cionni or Ahmed) can be used off-label to provide sutured scleral support to partially weakened capsula. However, in case of significant capsular or frenulum damage, the lens must be fixed without using this natural support structure. Other off-label techniques, such as iris stitching IOLs, can be employed, but these are technically difficult and can result in iris pigment loss leading to glaucoma. Finally, scleral suture IOLs with islets are technically complex, subject to rotation risk, and the durability of the suture is unknown; Cases of breakage and lens subluxation have been reported. Additionally, all of these technologies force surgeons to use alternative lens types in lieu of the lenses preferred to the patient. Finally, timing decisions are important, as lens calculations are often inadequate during initial vitrectomy/phacophagectomy, but patients do not wish to undergo additional posterior segment surgery, resulting in frequent implantation of less-than-ideal lenses.

In one aspect, an implantable device for supporting an intraocular lens within an eye is described, the device having a peripheral surface, an anterior facing surface, a posterior facing surface, and an overall thickness of the support structure between the anterior facing surface and the posterior facing surface. and a support structure having a single central aperture extending through the single aperture, the single aperture having a continuous inner circumference. The device includes a plurality of anchoring arms coupled to the support structure and configured to be placed in tension to position and stabilize the device within the eye. Each of the plurality of fixation arms has a distal end coupled to a trans-scleral anchor for sutureless scleral fixation.

The transscleral anchor may be configured to be externalized atraumatically. The transscleral anchor may be positionable outside the sclera and inside the conjunctiva. At least one of the plurality of anchoring arms may be substantially non-planar. The plurality of anchoring arms may include three anchoring arms extending outwardly from the outer circumferential surface of the support structure. At least a first of the three fixation arms may be biased toward the center of the device. At least a first fixation arm and a second fixation arm of the three fixation arms may each be biased towards the center of the device. Among the three fixing arms, a third fixing arm may have an increased cross-sectional area compared to cross-sectional areas of the first and second fixing arms. The increased cross-sectional area of the third fixing arm can increase its rigidity compared to that of the first fixing arm or the second fixing arm. The three fixing arms can be evenly distributed around the outer circumferential surface of the supporting structure.

The anterior facing surface may form a stable platform on which an intraocular lens is placed during use. The continuous inner circumference may form a uniform substantially circular shape, and the outer circumferential surface may form a substantially non-circular shape. In use, the support structure can provide centering of the device without 360 degree contact with the ciliary body along the substantially non-circularly shaped outer circumferential surface. In use, the substantially non-circularly shaped outer circumferential surface of the support structure may avoid contact with the ciliary body or may contact the ciliary body along less than 120 degrees. In use, the substantially non-circularly shaped outer circumferential surface of the support structure may contact ciliary processes at three distinct points. The outer circumferential surface of the support structure may include a plurality of lobes projecting outwardly from a plurality of substantially flat or concave sides. The plurality of lobes may include three convex lobes that give the support structure a substantially rounded triangular shape. The three convex lobes can provide anti-rotation in the Z-plane. In use, the three convex lobes can provide non-invasive contact with the ciliary body.

The support structure may include one or more slits formed in the inner wall defining a central aperture. The support structure may have a thickness from a front facing surface to a rear facing surface that tapers toward a central hole. At least one of the plurality of anchoring arms may include a plurality of anchors along its length including a transscleral anchor at a distal end. In use, the transsclera anchor may be configured to be positioned outside the sclera. The transsclera anchor may have a geometry configured to pass through the sclera in a first direction during insertion and resist pulling through the sclera in a second, opposite direction. When at rest, at least one of the plurality of anchoring arms may incorporate a bend between its starting point with the support structure and its distal end coupled to a transscleral anchor forming a bent anchoring arm. The bend may be between 90 and 270 degrees from the starting point in the radial and centripetal directions. The bend may be 180 degrees from the starting point with the support structure. When at rest, the distal end of the bent fixation arm may lie in a different plane than the plane of the support structure, and the transsclera anchor may be positioned over at least a portion of the support structure. The bent fixation arm may incorporate an elastic material or a deformable hinge to facilitate unfolding of the bent fixation arm such that the distal end approaches the plane of the support structure. The two fixation arms may be flexible and have an inward deflection and the third fixation arm may be less flexible than the two fixation arms. The transscleral anchor of each of the plurality of anchoring arms may be configured to be positioned outside the sclera. A transscleral anchor can include a central portion and one or more peripheral grippable portions. The central portion may be arranged such that the anchor is placed over the wound to be externalized upon implantation. The central portion may have an increased thickness, height, and/or width compared to the grippable portion. One of the plurality of fixing arms may be mechanically reinforced. Mechanical reinforcement may bias the device anteriorly upon implantation.

In a related aspect, a method of implanting an anterior capsule device having an artificial frenulum fixation that provides a stable platform for placement of an intraocular lens within an artificially constructed sulcus is provided.

In a related aspect, an implantable device for supporting an intraocular lens within an eye having a support structure lying substantially in a first plane is provided. The support structure has an outer circumferential surface, a front facing surface, a rear facing surface, and a single central hole extending through the entire thickness of the support structure between the front facing surface and the rear facing surface. A single hole has a continuous inner circumference. The device has three anchoring arms coupled to a support structure configured to position and stabilize the device within the eye. Each of the three fixation arms has a distal end coupled to a transscleral anchor for sutureless scleral fixation. When at rest, at least a first of the three fixed arms incorporates a bend between its starting point with the support structure and its distal end forming a first bent arm. The distal end of the first bent arm lies in a second plane different from the first plane.

The transsclera anchor of the first bent arm may be positioned over at least a portion of the support structure. The transscleral anchor of the bent arm may be positioned over at least a portion of the central aperture. At least a second of the three fixation arms may incorporate a bend between its starting point with the support structure and its distal end forming a second bent arm. The distal end of the second bent arm may lie in a second plane different from the first plane. The transscleral anchor of the second bent arm may be positioned over at least a portion of the support structure. The transsclera anchor of the second bent arm may be positioned over at least a portion of the central aperture. A third fixation arm of the three fixation arms may be straight between its starting point with the support structure and its distal end forming a straight fixation arm. The straight fixed arm may be less flexible than the first and second bent arms. The first and second bent arms may be biased toward a central axis of the device.

In a related aspect, an implantable device for supporting an intraocular lens within an eye having a support structure lying substantially in a first plane is provided. The support structure includes a perimeter surface, a front facing surface, a rear facing surface, and a single central aperture extending through the entire thickness of the support structure between the front facing surface and the rear facing surface. The single hole has an inner circumferential surface with a circumference. The device includes three anchoring arms coupled to the support structure and configured to be placed in tension to position and stabilize the device within the eye. Each of the three fixation arms has a distal end coupled to a transscleral anchor for sutureless scleral fixation. The inner circumferential surface forms a uniform substantially circular shape and the outer circumferential surface forms a substantially non-circular shape.

The non-circular shape of the outer peripheral surface may include a plurality of lobes projecting outwardly from a plurality of sides. The plurality of sides may be substantially flat or concave. Each of the three fixing arms may extend outwardly from each side of the plurality of sides. The support structure may have a width between an outer circumferential surface and an inner circumferential surface that varies around the circumference. Each of the three fixing arms may have a length longer than a distance at which the plurality of lobes protrude outward. The front facing surface and the back facing surface of the support structure may taper toward a central axis of the device. The inner and outer surfaces may be convex such that the inner surface projects toward the central axis of the device and the outer surface projects away from the central axis of the device. The thickness of the support structure from the front facing surface to the rear facing surface may be from about 0.15 mm to about 1.5 mm. The support structure may be substantially planar. The support structure may incorporate a recess in the forward facing surface. The support structure may incorporate one or more posts projecting upwardly from the forward facing surface.

In a related aspect, a device for implantation into the posterior chamber of an intact capsular bag free eye is provided. The device includes a support structure with a central opening. The support structure is configured to provide support for an artificial intraocular lens. After implantation into the eye, the device and artificial intraocular lens are configured to allow light to pass through both the aperture and the artificial intraocular lens. The device includes at least three anchoring arms extending substantially orthogonally from the support structure. Prior to implantation, one of the at least three anchoring arms extends from the support structure into a unfolded configuration and at least two of the at least three anchoring arms extends from the support structure into a collapsed configuration. One of the at least three fixation arms is biased toward the unfolded configuration and at least two of the at least three fixation arms are biased toward the collapsed configuration prior to implantation. Upon implantation, each of at least two of the at least three anchoring arms is extended. Each of the at least three fixation arms includes an atraumatic distal anchor portion for sutureless transscleral fixation of the device within the posterior chamber.

In a related aspect, a device for implantation into the posterior chamber of an eye lacking an intact capsular bag is provided comprising a support structure having a central aperture extending through the entire thickness of the support structure. The device includes a plurality of anchoring arms, each of the plurality of anchoring arms having a proximal portion on the support structure and a distal end portion coupled to an atraumatic anchor for sutureless transscleral fixation. Prior to transscleral fixation of the anchor, the plurality of fixation arms may include curved fixation arms curved between their proximal and distal ends enabling visualization of at least a portion of the curved fixation arms through the pupil of the eye. .

After anchoring the transsclera, each of the plurality of anchoring arms can be tensioned between the proximal and distal ends to align the support structure with respect to the Z-plane of the eye. The support structure can be configured to provide support for the intraocular lens and the central aperture can be configured to allow passage of light through both the intraocular lens and the central aperture supported by the support structure. The curved fixation arm can be bent forward and its atraumatic anchor can be positioned over at least a portion of the support structure. The curved fixation arm can be bent backwards and its atraumatic anchor can be positioned under at least a portion of the support structure.

In a related aspect, a method of implanting a device into the posterior chamber of an intact capsular bag-free eye is provided. The method includes inserting the device into the posterior chamber. The device includes a lens support structure having a central opening and at least three fixing arms. Each of the at least three anchoring arms has a proximal portion coupled to the lens support structure and a distal portion including an anchor. Prior to insertion into the rear chamber, at least one of the at least three anchoring arms is biased towards a linear configuration and at least a second of the at least three anchoring arms is biased towards a collapsed configuration. The folded configuration may include a beginning portion extending away from the lens support structure, a central portion including a bend, fold, or bend, and an end positioned above or below at least one of a portion of the lens support structure and a portion of the central opening. Contains the anchor of the part. The method includes gripping an anchor of at least one of the at least three fixation arms and externalizing the anchor through and over a first portion of the sclera. The method includes gripping an anchor of the second anchoring arm, unfolding the folded configuration of the second anchoring arm, and externalizing the anchor of the second anchoring arm through and over a second portion of the sclera. The method comprises gripping an anchor of a third fixation arm of the at least three fixation arms, tensioning the third fixation arm and externalizing the anchor of the third fixation arm through and over a third portion of the sclera to the posterior chamber of the eye. positioning and stabilizing the device within.

In a related aspect, a device for holding an artificial intraocular lens within an eye is provided. The device includes a lens support structure having a central aperture. When the device is implanted within the eye, light may pass through the central aperture towards the retina. The device includes at least three fixation arms, each of the at least three fixation arms having a start portion coupled to and extending outwardly from the lens support structure and a distal portion having an anchor for fixation of the device to the scleral membrane within the eye. Prior to implantation, at least one fixation arm of the at least three fixation arms is biased toward a folded configuration incorporating a bend between the proximal and distal portions that positions the anchor of the distal portion to overlap with at least a portion of the lens support structure. .

An anchor of the at least one fixation arm in the folded configuration may be positioned over at least a portion of the lens support structure and forward of the lens support structure relative to the retina, when positioned within the eye and prior to scleral fixation. An anchor positioned over at least a portion of the lens support structure may be over and in front of the central aperture of the lens support structure to the retina. At least a first portion of the anchor may be above and in front of the central aperture and at least a second portion of the anchor may be above and in front of the lens support structure to the retina. The anchors of the at least one fixation arm in the folded configuration may be positioned under at least a portion of the lens support structure and posterior to the lens support structure relative to the retina, when positioned within the eye and prior to scleral fixation. An anchor positioned under at least a portion of the lens support structure may be below and posterior of the central aperture of the lens support structure to the retina. At least a first portion of the anchor may be below and posterior of the central aperture and at least a second portion of the anchor may be below and posterior of the lens support structure to the retina. The folded configuration may include a distal portion folded above or below a start portion of the at least one anchoring arm. In the folded configuration, the distal portion of the at least one anchoring arm may overlap the initial portion. In the folded configuration, the anchors of the distal portion of the at least one fixation arm are visible through the pupil of the eye upon placement of the device in the posterior chamber of the eye but prior to fixation of the anchor to the dura. The anchors of the at least one fixation arm in the folded configuration may be positioned within a distance from a central axis of the device, the central axis extending anteriorly-rearwardly through the central opening. The distance may be about 4.0 mm or less. In the folded configuration, the at least one anchoring arm may be bent such that an anchor of a distal portion of the at least one anchoring arm protrudes back toward the central opening of the device. The anchor may be configured for sutureless transscleral fixation. The lens support structure may be substantially ring-shaped.

The lens support structure may further have an outer circumference and an inner circumference. The central opening may be defined by an inner circumference. The outer periphery of the lens support structure may be substantially non-circular and the inner periphery may be substantially circular. The lens support structure may include an outer periphery. The outer circumference may include a plurality of lobes projecting radially away from the central opening. A first numerical count of the plurality of lobes may be equal to a second numerical count of the at least three fixation arms. Each lobe may be spaced between adjacent anchoring arms. Each lobe may be symmetrically spaced around the outer circumference of the lens support structure between adjacent fixing arms. Each of the at least three fixing arms may be symmetrically spaced around the outer circumference of the lens support structure between adjacent lobes. The plurality of lobes may consist of three lobes. The at least three fixing arms may consist of three fixing arms. The plurality of lobes may include at least three convex lobes that give the lens support structure a substantially rounded triangular shape. When implanted, the at least three convex lobes can provide noninvasive contact with the ciliary tissue of the eye. At least two of the at least three anchoring arms may be biased towards the folded configuration prior to implantation. All of the at least three anchoring arms may be biased towards the folded configuration prior to implantation. At least a second of the at least three anchoring arms may be biased towards the deployed configuration prior to implantation. The at least second fixation arm may have a larger cross-sectional area compared to the cross-sectional area of at least one of the at least three fixation arms, such that the stiffness of the at least one fixation arm of the at least three fixation arms is greater than that of the at least second fixation arm. may provide increased stiffness. The lens support structure may form a substantially planar surface. The lens support structure may include a geometry configured to mate with a periphery of an intraocular lens or one or more haptics of an intraocular lens. The geometry may be a concavity, recess, channel or groove that forms at least a portion of the inner circumference of the lens support structure. At least one fixation arm of the at least three fixation arms may include a deformable material that facilitates unfolding of the fixation arm from a folded configuration to an unfolded configuration to facilitate fixation of the transsclera. After fixation of the anchor to the scleral membrane, the at least one anchoring arm may be tensioned in a stretched configuration between the proximal and distal ends to align the lens support structure with respect to the Z-plane of the eye.

The device may include three fixing arms. Two of the three anchoring arms may be flexible and may be biased toward a collapsed configuration. The third fixation arm may be less flexible than two of the three flexible fixation arms and may be biased towards the deployed configuration. All three fixation arms may be configured to be placed in tension. The folded configuration of each of two of the three fixation arms can bias the distal portion towards the central axis of the device. The lens support structure may be biased toward a substantially flat or planar configuration while at least one of the at least three anchor arms is biased toward a folded configuration.

In a related aspect, a device for holding an artificial intraocular lens within an eye is provided. The device includes a lens support structure having an inner circumferential surface at least partially defining a central aperture. When the device is implanted into the eye, light can pass through the central opening towards the retina. The device includes at least three fixing arms. Each of the at least three fixation arms has a proximal portion coupled to the lens support structure and a distal portion having an anchor for fixation of the device to the scleral membrane within the eye. Prior to implantation, at least one anchoring arm of the at least three anchoring arms is biased towards the folded configuration. The folded configuration includes a beginning portion extending away from the lens support structure and an anchor of a distal portion located above or below at least one of a portion of the lens support structure and a portion of the central opening, and a bend between the beginning portion and the distal portion. include

The anchors of the at least one fixation arm in the folded configuration may be positioned over and in front of a portion of the lens support structure to the retina when positioned within the eye and prior to scleral fixation. The anchors of the at least one fixation arm in the folded configuration may be positioned over and in front of a portion of the central opening to the retina when positioned within the eye and prior to scleral fixation. At least a first portion of the anchor may be over and in front of a portion of the central aperture and at least a second portion of the anchor may be over and in front of a portion of the lens support structure to the retina. The anchors of the at least one fixation arm in the folded configuration may be positioned under and posterior to a portion of the lens support structure to the retina when positioned within the eye and prior to fixation of the sclera. The anchors of the at least one fixation arm in the folded configuration may be positioned under and posterior to a portion of the central opening to the retina when positioned within the eye and prior to scleral fixation. At least a first portion of the anchor may be under and behind a portion of the central aperture and at least a second portion of the anchor may be under and posterior of a portion of the lens support structure to the retina. The folded configuration may include a distal portion folded above or below a start portion of the at least one anchoring arm. In the folded configuration, the distal portion of the at least one anchoring arm may overlap the initial portion. In the folded configuration, the anchors of the distal portion of the at least one fixation arm are visible through the pupil of the eye upon placement of the device in the posterior chamber of the eye but prior to fixation of the anchor to the dura. The anchors of the at least one fixation arm in the folded configuration may be positioned within a distance from a central axis of the device, the central axis extending anteriorly-rearwardly through the central opening. The distance may be about 4.0 mm or less. In the folded configuration, the at least one anchoring arm may be bent such that an anchor of a distal portion of the at least one anchoring arm protrudes back toward the central opening of the device. The anchor may be configured for sutureless transscleral fixation.

The lens support structure may be substantially ring-shaped. The lens support structure may further include an outer circumference and an inner circumference. The outer periphery may be substantially non-circular and the inner periphery may be substantially circular. The lens support structure may further include a perimeter comprising a plurality of lobes projecting radially away from the central aperture. A first numerical count of the plurality of lobes may be equal to a second numerical count of the at least three fixation arms. Each lobe may be spaced between adjacent anchoring arms. Each lobe may be symmetrically spaced around the outer circumference of the lens support structure between adjacent fixing arms. Each of the at least three fixing arms may be symmetrically spaced around the outer circumference of the lens support structure between adjacent lobes. The plurality of lobes may consist of three lobes, and the at least three fixation arms may consist of three fixation arms. The plurality of lobes may include at least three convex lobes that give the lens support structure a substantially rounded triangular shape. When implanted, the at least three convex lobes can provide noninvasive contact with the ciliary tissue of the eye.

At least two of the at least three anchoring arms may be biased towards the folded configuration prior to implantation. All of the at least three anchoring arms may be biased towards the folded configuration prior to implantation. At least a second of the at least three anchoring arms may be biased towards the deployed configuration prior to implantation. The at least second fixation arm may have a larger cross-sectional area compared to the cross-sectional area of at least one of the at least three fixation arms, such that the stiffness of the at least one fixation arm of the at least three fixation arms is greater than that of the at least second fixation arm. may provide increased stiffness.

The lens support structure may present a substantially planar surface. The lens support structure may include a geometry configured to mate with a periphery of an intraocular lens or one or more haptics of an intraocular lens. The geometry may include a concavity, recess, channel or groove forming at least a portion of the inner circumference of the lens support structure.

At least one fixation arm of the at least three fixation arms may include a deformable material that facilitates unfolding of the fixation arm from a folded configuration to an unfolded configuration to facilitate fixation of the transsclera. After fixation of the anchor to the scleral membrane, the at least one anchoring arm may be tensioned in a stretched configuration between the proximal and distal ends to align the lens support structure with respect to the Z-plane of the eye. The device may include three fixing arms. Two of the three anchoring arms may be flexible and may be biased toward a collapsed configuration. The third fixation arm may be less flexible than two of the three flexible fixation arms and may be biased towards the deployed configuration. All three fixation arms may be configured to be placed in tension. The folded configuration of each of two of the three fixation arms can bias the distal portion towards the central axis of the device. The lens support structure may be biased toward a substantially flat or planar configuration while at least one of the at least three anchor arms may be biased toward a folded configuration.

In some variations, one or more of the following may optionally be included in any practicable combination in the above methods, apparatus, devices and systems. More details are described in the accompanying drawings and description below. Other features and advantages will be apparent from the description and drawings.

These and other aspects will now be described in detail with reference to the following figures. Generally speaking, the drawings are not drawn absolutely or relatively to scale, and are intended to be illustrative. Also, the relative placement of features and elements may be modified for illustrative clarity.
1 shows a top view of an implementation of a device;
Figure 2 shows the device of Figure 1 deployed on an eye supporting an IOL;
Figure 3 shows a cross-sectional view of the device of Figure 1 deployed for supporting an IOL;
Figure 4 shows a cross-sectional view of the device of Figure 1 implanted within an eye supporting an IOL;
FIG. 5 shows a top view of the device of FIG. 1 with dotted lines indicating how the device may be slit to facilitate optical capture;
Fig. 6 shows a top view of the device of Fig. 1 with a flap integrated into the lens support structure to facilitate optical capture;
7a and 7b show various implementations of designs for securing footrests;
8A-8C show another implementation of a stationary scaffold coupled to the distal end of a stationary arm;
9 shows a top view of an implementation of a device with multiple anchors on each anchoring arm;
10 and 11 show perspective and top views, respectively, of an implementation of a device for supporting an IOL in which two of the fixation arms are curved and biased inward toward the center of the device and one fixation arm is straight;
12 shows an implementation of a device for supporting an IOL with a geometry such that the two fixation arms are curved and biased inward toward the center of the device, and one fixation arm is straight and more rigid than the other fixation arm;
Figure 13 shows a top view of an eye implanted with the device of Figure 12;
14A and 14B show various implementations of scleral incision guide tools that may be used to assist in the identification and marking of scleral incision sites;
15A-15D show various views of another implementation of a scleral incision guide tool;
15E-15G show the scleral incision guide tool of FIGS. 15A-15D positioned over the cornea;
15H-15I show the scleral incision guide tool of FIGS. 15A-15D with a crosshair;
16A-16D show additional views of the scleral incision guide tool of FIGS. 15A-15D;
Figures 17a and 17b show a straight tip fixing arm designed to bias the device forward to prevent rearward drift while securing the footrest externalization;
17c-17d show a snare device looped around a proximal anchoring arm and used to externalize a stationary scaffold;
Fig. 17e shows a cross-sectional view of the device of Fig. 17d;
18A and 18B show a further implementation of the snare device used to manipulate and externalize the foothold;
18C-18D show a further implementation of the snare device used to manipulate and externalize the foothold;
19A shows another implementation of the device prior to implantation, wherein the device has projections extending upwardly from the front facing surface of the support structure and anchoring arms biased inwardly toward the center of the device;
19B-19C show the device of FIG. 19A after implantation, with the IOL positioned over the central aperture and each fixation arm retracted;
20A shows another implementation of the device prior to implantation, wherein the device has a recess in the front facing surface of the support structure and a fixation arm biased inward toward the center of the device;
FIG. 20B shows the device of FIG. 20A after implantation, with the IOL positioned over the central aperture and each fixation arm tensioned;
20C is a cross-sectional view of the device of FIG. 20B showing the periphery of the IOL optic positioned against the recess surrounding the central aperture;
21A and 21B show another implementation of a device incorporating an enlarged central aperture and multiple leaflets;
FIG. 22A shows an interrelated implementation of a device with a fixed arm biased towards a folded configuration such that the arm is bent inward so that the anchor is positioned in front of and overlaps a portion of the central aperture and a portion of the lens support structure;
FIG. 22B shows an interrelated implementation of a device having a fixed arm biased towards a folded configuration such that the arm is bent inward so that the anchor is positioned in front of and overlaps a portion of the lens support structure;
23A and 23B show an interrelated implementation of a device with a fixed arm biased towards a collapsed configuration such that the arm is bent inwardly so that the anchor remains in the plane of the lens support structure;
24A-24F show interrelated implementations of a device having a shading configured to receive an IOL;
25A-25C depict another implementation of a device having a visor configured to receive an IOL;
26A-26E show another implementation of a device having a shading configured to receive an IOL;
27 shows another implementation of a device having a visor configured to receive an IOL;
It should be understood that the drawings herein are for illustrative purposes only and are not intended to scale.

The present disclosure relates to the field of ophthalmology in general, and more particularly to ophthalmic devices comprising prosthetic support structures that can be used to support an intraocular lens (IOL) or other ophthalmic implant when the frenulum and capsular support are damaged. .

The most common treatment for aphakia caused by removal of the cataract lens is placement of an IOL within the capsular bag of the natural lens. The capsular bag, which has anterior and posterior components and thus creates an internal chamber, is supported by the frenulum to provide a stable structure for the IOL support. In some cases, the posterior aspect of the capsular bag is incapacitated or ruptured during cataract surgery, requiring a more stable platform for positioning the IOL. If the anterior aspect of the capsular bag and its associated frenulum are intact, the IOL may be placed between the anterior capsule and the iris, a location referred to as the "sulcus". In another subset of cataract surgery cases, the anterior capsule is incompetent, or the zonule is incompetent, making sulcus placement unsafe or impossible. The devices described herein can be implanted in the posterior chamber of an eye that lacks an intact capsular bag. The devices described herein may utilize artificial frenulum fixation to create an artificial anterior capsule. The device described herein can provide a stable platform structure anchored to the eye, thereby replicating the natural anterior capsule and frenulum device that allows placement of an IOL in an artificially constructed sulcus.

The devices described herein can solve the problems of other support/positioning techniques known in the art. Anterior chamber intraocular lenses placed in front of the iris can cause corneal decompensation, glaucoma and hemorrhage over time due to ocular instability. A lens sutured to the iris is technically difficult to implant and there is a risk of hemorrhage and glaucoma due to iris friction. The lens can also be sutured to the sclera, which is also technically difficult. In some cases, there is a risk of infection requiring additional surgery and potentially blinding due to suture erosion/breakage.

The devices described herein can be implanted in a sutureless fashion that eliminates the risk of suture breakage. A sutureless transsclera fixation method allows for easier placement and secure attachment without fear of suture loosening or breaking. The device holds the IOL stable, providing reliable refraction results based on known positions without concern. The device also enables posterior segment placement that greatly reduces the risk of damage to the iris, angle or cornea. Posterior transplantation of the iris and cornea eliminates or reduces the risk of corneal damage, iris hemorrhage, and glaucoma. The devices described herein reduce the risk of complications compared to current technologies such as ACIOL, iris closure lenses, or scleral closure lenses. The devices described herein are designed to accommodate and support a wide variety of intraocular lenses. Thus, the lens of choice can be implanted at the time of surgery or later. The device described herein is particularly suitable for replicating a natural capsular bag and for implantation into the posterior chamber of an eye that lacks an intact capsular bag. For example, the device described herein uses artificial zonal fixation to create an artificial anterior capsule, thus creating a scaffold or stable platform structure and an artificially constructed sulcus if the anterior component of the capsular bag and/or zonal lens of the natural lens is incapacitated. can provide. The fixation arm can be externalized as needed for scleral support/fixation.

1-4 show an implementation of device 100 . Device 100 may include a lens support structure 105 over, against or within which IOL 110 may be supported, a central aperture or hole 115, and one or more fixation arms 120. Central aperture 115 is configured to prevent device 100 from obstructing the patient's vision and to allow light to pass through aperture 115 as well as IOL 110 positioned in device 100 . The size of the central hole 115 allows light to pass through the device without any optical disturbance. Light can travel through the device towards the retina and is only affected by the optics of the IOL. One or more fixation arms 120 may position and stabilize the device 100 within the eye. The lens support structure 105 may include an outer periphery 111 and an inner periphery 109 and a central aperture 115 may be defined by the inner periphery 109 . The lens support structure 105 may be generally ring-shaped, but the outer periphery 111 of the lens support structure 105 need not be circular as described in more detail below. The outer periphery 111 of the lens support structure may be substantially non-circular when the inner periphery 109 is substantially circular.

1 shows a top view of device 100 showing lens support structure 105 , central aperture 115 , and fixation arm 120 . 2 shows a model of the eye with a 3/4 view of device 100 deployed to support IOL 110 (iris illustrated transparently). The lens support structure 105 may serve as support for the IOL 110 during optimal implantation and may act as a guard for the IOL 110 falling into the posterior chamber during implantation. The lens support structure 105 may replace the capsular bag of the natural lens, particularly where the anterior aspect and associated frenulum are incapacitated, making sulcus placement of the IOL unsafe or impossible. Placement of the lens support structure 105 in a patient without a satisfactory capsular bag can create an anterior capsular device. The fixation arm 120 is a stable platform for placing an intraocular lens in an artificially constructed sulcus, and may provide an artificial zonal fixation to stabilize the lens support structure. 3 shows a cross-sectional view of device 100 deployed to support IOL 110 and a model of an eye. FIG. 4 shows a model of the eye in cross-section showing how the lens can be deployed to support the IOL using optical capture technology. 4 shows the cornea 5 , the iris 10 , the ciliary body 15 , the sclera 20 , the ciliary sulcus 25 , and the pupil 30 centrally defined through the iris 10 .

In some implementations, the support structure 105 can be substantially planar or planar. The support structure 105 has an anterior facing surface 1210 that is oriented towards the front of the eye when the structure 105 is in use and a rear facing surface 1215 that is oriented towards the back of the eye when the structure 105 is in use. may have (see FIG. 17e). The planar support structure 105 can act as a platform on which the IOL can be placed. The planar anterior and posterior surfaces need not include any protrusions, channels or capture components for holding the IOL thereon. For example, the support structure 105 may create an artificial anterior segment of the capsular bag for the IOL to be positioned against, but need not retain the IOL within the interior surface. Thus, the IOL may remain completely outside of the support structure 105 during use, and there are no protrusions, overhangs, or other surfaces positioned against the IOL other than the substantially planar surface of the support structure 105 . Accordingly, each of the front facing surface and the back facing surface may be a substantially smooth planar surface without any protrusions or overhangs above the surface. Each of the front facing and rear facing surfaces may also be free of any indentations, grooves, divots, or openings other than a central hole 115 extending through the surfaces. The substantially flat support structure 105 may taper toward the central hole 115 . The tapered edge or inner wall 109 defining the hole 115 has a front-to-back thickness that is less than the front-to-back thickness of the supporting structure away from the hole 115 .

In other implementations, the support structure 105 can incorporate one or more protrusions that extend away from at least one of the front facing surface and the rear facing surface. 19A-19C illustrate an implementation of a support structure 105 having a plurality of posts 106 protruding upwardly away from the front facing surface near the central aperture 115. A plurality of posts 106 may be positioned around the central hole 115 to surround the optics of the IOL when positioning the IOL over the hole 115 (see FIGS. 19B-19C ). Post 106 may be placed abutting or adjacent to the periphery of the optic such that the IOL is received and centered by post 106 to limit translational and/or rotational movement of the IOL relative to support structure 105 . Post 106 may also be positioned on the anterior facing surface (or posterior facing surface) to engage the area of the IOL haptic that extends outward from the optic. Post 106 can be universally arranged to accommodate most IOL designs.

In another implementation, the support structure 105 may optionally or additionally include a recess in at least one of the anterior facing surface or the posterior facing surface that is sized and shaped to receive the IOL (described in more detail below). See Figures 20a to 20c). The recess may be a central inward facing groove for receiving an IOL and/or an IOL haptic as described, for example, in PCT Publication No. WO 2020/086312, published Apr. 30, 2020, incorporated herein by reference. can

20A-20C illustrate another implementation of a device 100 having a support structure 105 that includes a recess 104 in the front facing surface. Recess 104 may form a lip surrounding a central hole 115 sized to engage and support the periphery of the optic of the IOL against the lip (see FIG. 20C ). Recess 104 in the central 6.0-7.0 mm portion of support structure 105 may limit translational movement of the optic. Recess 104 may further incorporate a concave dish-shaped section to increase the interfacial surface area of the support structure 105 and the IOL. Recess 104 may incorporate one or more features that further prevent rotational movement around the visual axis or central axis (CA) of the device. 24A-25F, 25A-25C, and 26A-26E illustrate further implementations of devices incorporating a recess within which an IOL may be received, described in more detail below.

Regardless of whether support structure 105 is concave and/or incorporates one or more protrusions from its surface, the anterior-posterior thickness of support structure 105 is minimized to avoid impinging on iris 10. .

Support structure 105 may include one or more surface features in or on front facing surface 1210 and/or back facing surface 1215 . 1 shows that support structure 105 can include surface features 118 on anterior facing surface 1210 that can be used to position device 100 during implantation. Surface feature 118 may engage forceps or other implantation tools to aid in manipulation of device 100 during implantation.

The central aperture 115 may extend through the entire thickness of the support structure 105 from the front facing surface 1210 to the rear facing surface 1215, such that the support structure 105 defines the central aperture 115. and an outer wall 111 having an outer circumferential surface defining the overall shape of the support structure 105 (see FIG. 1 and also 17e). This may give the lens support structure 105 a substantially annular shape. However, the annular lens support structure 105 need not be circular on both its inner and outer circumferential surfaces. The inner circumferential surface may have a circumference and may form a uniform substantially circular shape, while the outer circumferential surface may form a substantially non-circular shape. As described in more detail below, the non-circular shape of the outer peripheral surface includes a plurality of lobes 107 projecting outwardly from a plurality of side surfaces 108 . A plurality of lobes 107 may protrude radially away from the central hole 115 . The plurality of sides 108 may be substantially flat or concave as described elsewhere herein. In some implementations, the device includes at least three fixation arms 120 coupled to a lens support structure 105 configured to be placed in tension to position and stabilize the device within the eye. Each of the three fixation arms 120 may extend outwardly from each side of the plurality of sides 108 . Thus, the lens support structure 105 may have a width between the outer circumferential surface and the inner circumferential surface that varies around the circumference. The central hole 115 is designed to see through the device. In some implementations, the support structure 105 is substantially flat and the IOL sits on an anterior facing surface (or a posterior facing surface) of the support structure 105, but is not retained or received by the central aperture 115. In another implementation, the support structure 105 is generally planar, but has a rib surrounding the central aperture 115 such that an IOL seated on the anteriorly facing surface of the support structure 105 engages the lip formed by the recess 104. and set 104 (see FIG. 20C). The support structure (and thus the central aperture 115) may have a minimized anterior-posterior thickness. The thickness of the support structure 105 between the front facing surface 1210 and the back facing surface 1215 may be between about 0.15 mm and 1.5 mm, or between about 0.5 mm and 1.0 mm. The thickness of the support structure 105 can be less than 0.15 mm and still provide sufficient support for the IOL due to the fixation arm 120 being in tension, for example. The inner circumferential surface or inner wall 109 defining the central hole 115 may be smooth and free of any depressions, grooves, channels or other surface features. In some implementations, the inner circumferential surface or inner wall 109 is convex and protrudes toward the central axis CA of the device, and the outer circumferential surface or outer wall 111 is also convex and protrudes away from the central axis CA of the device. do. The convex inner and outer peripheral surfaces formed by the inner and outer walls 109, 111 can create a cross-sectional shape for the support structure 105 when taken over the center of the central hole 115 forming a pair of round rods. there is. In some implementations, the front facing surface 1210 and the back facing surface 1215 are shaped as a single narrow ridge or point 1230 where the inner circumferential surface of the inner wall 109 protrudes toward the central axis CA of the device. Each tapers toward the central hole 115 as much as possible (see Fig. 17e).

The central hole 115 may also be the only hole that extends through the support 105 such that the support 105 has only a single hole extending through its entire thickness. The inner diameter of aperture 115 is generally designed to be universal for a wide range of IOL types. The aperture 115 is sized to prevent the support 105 from substantially overlapping the optics of the IOL. Conventional IOLs typically have optics with an outer diameter of 6 mm, but this size can vary depending on the IOL. Devices with a central hole 115 inner diameter of less than 5.0 mm to about 4.0 mm may be used with some IOLs. A device having a central hole 115 inner diameter of 5.0 mm to about 6.0 mm can be used with most IOLs such that the device is nearly universal for use with any conventional haptically-stabilized IOL. The minimum inner diameter of hole 115 is greater than about 4.0 mm, greater than about 4.5 mm, greater than about 5.0 mm, greater than about 5.5 mm, greater than about 6.0 mm, greater than about 6.5 mm, less than about 7.0 mm, less than about 8.0 mm, and less than about 9.0 mm. mm or less, about 10 mm or less, and any range in between.

The inner diameter of hole 115 may be larger than the outer diameter of the IOL optic. 21A and 21B illustrate an implementation of a device 100 having a central hole 115 with an inner diameter larger than most IOL optics. Device 100 may include a plurality of leaflets 126 configured to support optics of an IOL. Leaflet 126 may project inwardly to extend within the opening of central hole 115 . Leaflet 126 may support an optic on a forward facing surface or it may be biased such that the optic is directed to and supported by a rear facing surface of leaflet 126 . The IOL's haptics can remain on the anterior facing surface of support 105 and the IOL's optic can be placed on the posterior facing surface of leaflet 126 to maintain the IOL's Z-position. Leaflet 126 may be full thickness or partial thickness. That is, leaflet 126 can be as thick as support structure 105 or thinner than support structure 105 . A leaflet 126 may protrude from the front facing surface of the support 105 (see FIG. 21A). Leaflet 126 may also protrude from the rear facing surface of support 105 (see FIG. 21B). When protruding from the posterior facing surface, the optic of the IOL may be positioned within a recess formed by the central aperture 115 and the anterior facing surface of leaflet 126 . Device 100 may include one, two, three or more leaflets 126 . In an implementation, device 100 includes three leaflets 126 and three stationary arms 120 . Each of the three leaflets 126 may be symmetrically arranged about the support 105 such that each leaflet 126 is substantially aligned with the starting point of each of the anchoring arms 120 . 21A and 21B show each bent anchor arm 120a, 120b bent from its starting point in the support structure 105 to be positioned substantially over its respective leaflet 126. The leaflet 126 may define an inner diameter smaller than the inner diameter of the central hole 115 . The narrower inner diameter of leaflet 126 may be between about 4.0 mm and 6.0 mm, or between about 5.0 mm and 5.5 mm, or between about 5.0 mm. Each leaflet 126 may have a thickness that is between about 0.10 mm and 0.50 mm, or between about 0.15 mm and about 0.35 mm, or between about 0.25 mm.

One or more of the anchoring arms 120 may be substantially straight between their starting point with the support structure 105 and their distal end. The straight anchoring arm or proximal anchoring arm 120 may extend along a single longitudinal axis L between the starting point 103 and the distal end 102 without any bends or curvatures away from the single longitudinal axis L. (See FIGS. 17a and 17b). The straight anchoring arm(s) 120 may extend orthogonally to the outer circumferential surface of the outer wall 111 of the support structure 105 . The longitudinal axis L of the straight anchoring arm(s) 120 may be positioned perpendicular to the outer circumferential surface of the outer wall 111 . The plane of the front facing surface 1210 of the support structure 105 and the longitudinal axis L of the straight anchoring arm(s) 120 are the same as the plane and longitudinal axis L of the rear facing surface 1210 of the support structure. can be parallel to each other as well.

The one or more fixation arms 120 may be transscleral fixation arms that are atraumatically externalized and designed to remain in place by their geometry and mechanical properties alone, ie without the need for sutures or adhesives. An externalized portion or anchor 125 (also referred to herein as a stationary scaffold or scaffold) at the peripheral end (also referred to herein as a distal end or distal portion) of anchoring arm 120 is seated under the conjunctiva to form an arm (120) can be locked in place. The anchor 125 of the fixation arm 120 may have a rigid but low profile geometry to remain stable, not re-enter the eye, and minimally erode the conjunctiva. Additionally, the fixation arm 120 of the device 100 may be manufactured in a manner that facilitates easy visualization and manipulation of the device prior to surgery. At least one of the anchoring arms 120 may be manufactured to have a substantially non-planar geometry in a resting state and then be manipulated into a planar configuration during the implantation procedure and when placed in tension, for example.

The device 100 may include one, two, three or more fixed arms 120 . In a preferred implementation, the device 100 includes three anchoring arms 120 arranged symmetrically or equidistantly around the periphery of the support structure 105 . The fixation arm 120 can center the lens support structure 105 and provide sufficient support for long-term stability. In some implementations, this may be achieved by a single anchoring arm 120 . In another implementation, the one or more fixation arms include three fixation arms 120 symmetrically arranged around the periphery of the lens support structure. The anchoring arm 120 may be constructed from a semi-rigid material or may have a geometry that provides sufficient structural rigidity.

Device 100 may also include only two fixing arms 120 . These anchoring arms 120 may be in the same opposing tension when implanted and anchored to the dura. Alternatively, the fixation arms 120 can be asymmetrical such that one fixation arm 120 is in tension and the other fixation arm 120 has a stiffness and length that functions as a rigid spacing element. The fixation element, which may be rigid or capable of applying a spring force, may depend on penetration of adjacent tissue or being fixed in place. A tensioned anchoring element can be subject to slight elongation or expansion of the material once placed. One or both of the anchoring arms 120 may be created in an inwardly biased configuration where the anchoring arms are biased toward a forward projecting bend or a folded configuration described elsewhere herein. The fixation arm 120 may have a paddle-like geometry that resists rotation when engaged with ocular tissue.

Device 100 may also include three or more stationary arms 120 . The three fixation arms 120 may provide the device 100 with a defined fixation plane that is substantially parallel to the Z-plane (vertical plane) of the eye. The anchoring arms 120 may be designed and deployed in such a way as to place each anchoring arm 120 in equal and opposite tension. Alternatively, one or more of the anchoring arms 120 may be designed with a stiffness and length to allow them to behave as rigid spacing elements. Zero, one, two or all three or more anchor arms 120 may be fabricated in an inward deflection design or may be biased towards the center of the device or the central axis CA of the device (Figs. 10-13). , 17b to 17e, 19a, 20a, 21a and 21b, 22a and 22b, 23a and 23b, 24a to 24f, 25a to 25c and 26a to 26e) . The inwardly biased fixation arm 120 may extend from the support structure and may have a collapsed configuration prior to implantation. At least one, but less than all, of the anchoring arms may be deflected or bent as described herein. At least two, but less than all, may be deflected or curved as described herein. In some implementations, all anchor arms 120 may be biased or curved. The device may include three fixation arms, two of the three fixation arms being flexible and biased toward the collapsed configuration, and a third fixation arm being less flexible than the other two and being biased toward the unfolded configuration. biased The folded configuration of each fixation arm may bias the distal end of the fixation arm towards the central axis CA of the device. The lens support structure may be biased toward a substantially flat or planar configuration while the fixation arm(s) are biased toward a substantially flat or non-planar folded configuration.

Once implanted and secured to the scleral membrane, the inwardly biased arms can be unfolded or unfolded from the folded inwardly biased configuration. In a preferred implementation, the two anchor arms 120 have an inward deflection geometry and the third anchor arm 120 has an increased cross-sectional area, which increases its stiffness. The inward deflection fixing arm 120 may incorporate a bend between the starting point of the arm with the lens support structure 105 and its distal end. The two bent fixation arms 120 can be biased towards the central axis CA of the device towards a collapsed configuration.

In implementation, device 100 may include at least three stationary arms 120 . Prior to implantation, one of the at least three anchoring arms may extend from the support structure into a unfolded configuration, and at least two of the at least three anchoring arms may extend from the support structure into a collapsed configuration. And, prior to implantation, one of the at least three anchoring arms may be biased towards the unfolded configuration and at least two of the at least three anchoring arms may be biased towards the collapsed configuration. After implantation, each arm biased towards the folded configuration can be unfolded.

Each anchoring arm 120 may include a proximal portion 103 in a support structure 105 and a distal end portion 102 coupled to an atraumatic anchor 125 for sutureless transsclera fixation. Before fixation of the anchor 125 to the scleral membrane, one of the plurality of fixation arms 120 (up to all fixation arms 120) is bent between its beginning portion 103 and its distal end 102 so that the pupil of the eyeball ( 30) (see FIGS. 13 ) and a curved fixation arm 120 forming a bend B (see FIGS. 22A and 22B ) enabling visualization of at least a portion of the curved fixation arm 120 . can do. After fixation of the anchor 125 to the scleral membrane, each of the plurality of fixation arms 120 may be tensioned between the proximal and distal ends to align the support structure with respect to the Z-plane of the eye. Support structure 105 is configured to provide support for an intraocular lens. A central aperture 115 extending through the entire thickness of the support structure 105 is configured to allow passage of light through both the central aperture 115 and the IOL supported by the support structure 105 . The curved anchoring arm 120 is such that the distal end 102 and/or a portion of the arm 120, such as its atraumatic anchor 125, is over at least a portion of the support structure 105 (e.g., the support structure 105 and/or over the region of the central hole 115). Alternatively, the curved anchoring arm(s) 120 may have a distal end 102 and/or a portion of the arm 120, such as its atraumatic anchor 125, underneath at least a portion of the support structure 105. It may be bent backwards to be positioned (eg, below the lower surface of the support structure 105 and/or in the area of the central aperture 115).

19A and also FIG. 20A illustrate the implementation of the device prior to implantation. 19B-19C and also FIGS. 20B-20C illustrate the device after implantation. Two of the three fixation arms 120 are bent inward to bias towards a folded configuration in a rest state. Arm 120 extends outwardly substantially orthogonally from support structure 105 such as from its origin 103 in support structure 105 and extends between the origin 103 and distal end 102 of arm 120. Make a turn (forward or backward) that forms a bend. The curvature of the arm 120 may cause the distal end 102 of the arm 120 to be positioned closer to its initial portion 103 . In some implementations, the arm 120 is such that the distal end 102 of the arm 120 is forward of or proximate the start 103 of the arm 103 to the front facing surface of the support structure 105 . It is curved in the forward direction so as to be positioned over at least a portion of the. In another implementation, the arm 120 is such that the distal end 102 of the arm 120 is behind or proximate the beginning 103 of the arm 103 to the rear facing surface of the support structure 105 . It may be curved in a rearward direction so as to be located under at least a portion of the . In an implementation, the anchor 125 of the curved fixation arm 120 can be curved from a first plane of the support structure (eg, the Z-plane of the eye) to a second plane parallel to the first plane. The second plane may be in front of or behind the first plane depending on whether the arm 120 is curved forward or backward. The curvature may be in a direction substantially transverse (eg, X-plane) to a plane (eg, Z-plane) of the lens support structure 105 . The dilated pupil (depending on the adult or pediatric patient) may have a diameter of about 8 mm or less. The curvature is located within the diameter of a circle in the second visible plane within the diameter of the dilated pupil, for example from about 3 mm to about 7.5 mm, more preferably about 7 mm, so as not to interfere with visualization by the opaque iris. Position the anchor 125 of the fixed arm 120 bent as much as possible. The anchor 125 of each of the curved fixing arms 120 is a certain distance from the center of the device, for example about 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, about 3.5 mm or less, or about 4.0 mm from the center of the device. may be located below. A curved arm 120 is provided to position the distal end portion 102 and/or anchor 125 within this diameter or this distance from the center of the device to facilitate visualization. A third of the three fixation arms 120 is deflected from rest to a straight or extended configuration. The third arm 120 extends outwardly orthogonally from its starting point 103 in the support structure 105, making no turns or bends. Rather, the entire third arm 120 is completely straight and extends substantially along a single axis. The two anchor arms, biased towards the collapsed configuration in the resting state, are now in the deployed configuration, for example by tensioning the arms 120 via externalized transscleral anchors.

The fixing arm 120 may be uniformly distributed around the device 100 to provide a uniform tension. Alternatively, the fixation arms 120 can be oriented in a non-uniform distribution, for example using three fixation arms 120 that are 90 degrees from each other. In this situation, two of the fixing arms 120 are 180 degrees from each other to provide opposing tension; The third fixing arm 120 mainly serves to prevent the device 100 from rotating.

The lens support structure 105 can serve several functions. Lens support structure 105 may have a surface (anterior facing surface 1210 or posterior facing surface 1215) that forms a stable platform on which IOL 110 may be placed during use. The lens support structure 105 may replace a capsular bag, particularly a bag in which the posterior and/or anterior aspects of the bag have been ruptured or otherwise incompetent. Its geometric and mechanical function may serve to support the IOL 110 in use, as well as assist in the centering of the IOL 110 in the case of an asymmetric ocular or asymmetric surgical procedure. The lens support structure 105 may be coupled to one or more fixing arms 120 . Where lens support structure 105 provides artificial anterior capsule support for an IOL, fixation arm 120 provides a prosthetic zonal device. Thus, the device generally provides a stable platform structure anchored to the eye that replicates the natural anterior capsule and frenulum apparatus allowing placement of the IOL. The geometry and mechanical properties of the lens support structure 105 can be designed to allow the fixation arm 120 to function as intended and also to withstand any torsional or tensile forces that may be imparted by the fixation arm 120 .

The fixation arm 120 and lens support structure 105 are designed to position the central aperture 115 in such a way that a properly secured device 100 does not obstruct the patient's vision. A surgeon may place the IOL 110 through the lens support structure 105, thereby providing the necessary refractive correction to the patient.

The ciliary body has a substantially circular or elliptical shape and the vertical axis is on average 0.5 mm longer than the horizontal axis. The lens support structure 105 may abut the patient's ciliary body to provide centering of the device 100 within the eye. A substantially circular or elliptical lens support structure 105 may similarly provide centering for a circular or elliptical ciliary body. However, the 360 degree contact and shape matching between the lens support structure 105 and the ciliary body can result in inflammation or damage, which can negatively affect aqueous production. In a preferred implementation, the lens support structure 105 has a substantially non-circular geometry and a continuous inner circumference defining a uniform, substantially circularly shaped inner wall 109 defining a central aperture 115 ( 105) (see FIG. 1) and has an outer peripheral surface forming a substantially non-circular shaped outer wall 111. The non-circular outer geometry of the lens support structure 105 can provide centering of the device 100 without 360 degree contact with the ciliary body along a substantially non-circular shaped outer circumferential surface. The shape of the lens support structure 105 provides sufficient contact between the lens support structure 105 and the ciliary body to help center and support the IOL 110 without causing inflammation and damage. In some implementations, the shape of the lens support structure 105 allows for contact with the ciliary body that is about 120 degrees or less, preferably 1 to 45 degrees, or 1 to 20 degrees. Restricting contact to less than 120 degrees greatly reduces the risk of inflammation or damage to aqueous production. The substantially non-circular or elliptical lens support structure 105 allows for gentle contact between the device 100 and the ciliary body providing centering without having to precisely match the patient's specific dimensions. The radius of curvature of the lens support structure 105 may be smaller than the radius of curvature of the ciliary protrusion. Thus, the lens support structure 105 may contact the ciliary projection at three distinct points rather than over a calculable range. For example, in use, the substantially non-circularly shaped outer circumferential surface of the lens support structure 105 may contact the ciliary protuberance at these three distinct points. In another implementation, the lobe 107 of device 100 is positioned proximal, but avoids contact with ocular tissue (eg, ciliary body) once each anchoring arm 120 is implanted and placed in tension. This arrangement allows the lobes 107 to help center the device and prevent excessive tension of one arm 120 relative to the other arm 120 . If the fixation arm 120 is pulled excessively during externalization of the anchor 125, the neighboring lobes 107 on either side of that fixation arm 120 abut against the ciliary body and support the support structure 105 during implantation. It pushes away from the parent body and promotes the device 100 to a more central alignment. Once implanted, the lobes 107 of the device may be placed proximate to ocular tissue (eg, the ciliary body) with or without contact with ocular tissue. The tensioned anchoring arm 120 can pull the support structure 105 substantially equally around its periphery. The tension applied around the support structure 105 can substantially align the central axis CA of the device 100 extending through the central aperture 115 with the visual axis of the eye and the planar surface of the support structure 105. It can be stabilized substantially parallel to the Z-plane (vertical plane) of the eye. The central axis CA of the device 100 does not have to be perfectly aligned (matched) with the visual axis of the eyeball.

The non-circular outer wall 111 of the lens support structure 105 may include a plurality of lobes 107 projecting outwardly (ie, in a convex manner) from a plurality of sides 108 that are substantially flat or concave. This may form the outer wall 111 of the lens support structure 105 having an alternating pattern of convex lobes and concave or flat sides. In a preferred implementation, the lens support structure 105 includes three convex lobes 107 or three flat or slightly concave sides 108 with rounded corners protruding between them to give the lens support structure 105 a triangular or rounded triangular shape. (See FIG. 1). The lobe 107 provides anti-rotation in the Z-plane to maintain proper alignment between the central aperture 115 and the visual axis of the eye (see FIG. 4) and/or prevents displacement within the Z-plane. may act as a bumper against the ciliary body 15 and/or within the ciliary furrow 25. A plurality of stationary arms 120 may be positioned on the side surface 108 and a plurality of lobes 107 project outwardly between the plurality of stationary arms 120 . Each of the fixing arms 120 may have a length longer than the distance at which the lobe 107 protrudes outward. As noted above, the lens support structure 105 may have a circular inner wall 109 defining a central aperture 115 . A plurality of lobes 107 protruding outward from the central aperture 115 provide varying thicknesses in the plane of the central aperture 115 between the inner wall 108 and the outer wall 111 . The thickness of the lens support structure 105 between the inner wall 108 and the outer wall 111 at the position of the substantially flat side 108 is the thickness of the inner wall 108 and the outer wall 111 at the position of the lobe 107. less than the thickness of the lens support structure between them. The number of lobes 107 forming the rounded corner of the lens support structure 105 may include a round triangle, a round rectangle, a round pentagon, a round hexagon, a trefoil, a quatrefoil, a cinquefoil ( cinquefoil) and the like to provide any of a variety of non-circular shapes. The protrusions or corners of these non-circular geometries can be rounded to provide smooth, non-intrusive contact with ciliary tissue, such as the ciliary body. Alternatively, device 100 may be designed to utilize a planar portion or scleral wall for centering assistance. In this implementation, device 100 may be positioned posterior to the ciliary process.

The plurality of lobes 107 may include at least three convex lobes that give the lens support structure 105 a substantially rounded triangular shape. A first numerical count of the plurality of lobes 107 may be equal to a second numerical count of the at least three fixation arms 120 , each lobe 107 being spaced between adjacent fixation arms 120 . The lobes 107 may be symmetrically spaced around the outer circumference of the lens support structure between adjacent fixing arms. Each of the at least three fixing arms 120 may be spaced symmetrically around the outer circumference of the lens support structure 105 between adjacent lobes 107 .

Each anchoring arm 120 may have a spring force that is a function of the elongation of the material when under load. Alternatively, an open-loop haptic or coil spring may have a spring force provided due to bending of a material having a substantially fixed length. Once fixed to the eye, the fixation arm 120 may be in a state of tensile stress and material elongation. For example, each anchoring arm 120 may provide an extension over a radius of about 7.5 mm to about 8.0 mm to accommodate a diameter of about 15 mm to about 16 mm. The device has an operable tension range for functioning. As an example, the device may be in a first amount of tension (X tension) once implanted. The first amount of tension is the amount of tension of the minimum allowable diameter. In other words, the device is under a minimal amount of tension to function, but can be placed under a higher tension to accommodate a larger diameter. In the example of a stationary arm 120 capable of accommodating both 15 mm and 16 mm extensions, each force transmission arm can operate in a first tension (X) state and at least a second tension state. The second tension may be the sum of the first tension (X) plus the tension distance (eg, tension of 0.5 mm). The fixed arm can withstand the differential tension available at each extension ratio. To further illustrate an example, if the length of each anchoring arm 120 in this implementation is approximately 4 mm, the second tension (X tension + 0.5 mm tension) functions at 15 mm diameter and also up to 16 mm diameter. It can increase elongation by 12.5% to function. In this example, if the length of the fixed arm 120 is 2 mm, the second tension (X tension + 0.5 mm tension) can function at 15 mm diameter and also increase the elongation by 25% to function up to 16 mm diameter. there is. In this implementation, if the length of the fixed arm is about 6 mm, the second tension (X tension + 0.5 mm tension) can function at 15 mm diameter and also increase the elongation by 6.25% to function up to 16 mm diameter. The reduced spring force of the fixation arm 120 will improve the safety and function of the device because the tension of the anchor against the ocular tissue is less dependent on parameters that are difficult for the surgeon to evaluate - the intrinsic dimensions of the eye and the specific location of the incision. can Additionally, the length of the fixation arm (eg, about 2 mm to 6 mm) as well as the inward curvature (anteriorly or posteriorly) of at least one fixation arm 120 provides the surgeon with access to locate and secure the arm during surgery. and improve visualization.

If only one, two or three fixation arms 120 are engaged, it may be possible for the IOL 110 to pass between the device 100 and the ciliary process. A lens support structure 105 designed to contact or nearly contact the ciliary body may also reduce the risk of losing the IOL 110 into the posterior chamber during surgery.

Lens support structure 105 may be configured to allow a surgeon to use “optical capture” technology for implantation of IOL 110 supported by device 100 . In this technique, optic 112 of IOL 110 partially or completely passes through central aperture 115 of device 100 while haptic 114 of IOL 110 is substantially forward of device 100. remains (see Figure 3). This technique provides secure fixation of the IOL 110 so that it cannot drift in the X, Y or Z axis after surgery and reduces the bulk of the lens anterior space. This technology further relieves the IOL from contacting the posterior surface of the iris 10, allowing safe use of "square edge" IOL designs. Surgeons have added flexibility to IOL manipulative correction by providing effective lens positioning choices. This technique also allows the use of astigmatism correcting IOLs by limiting IOL rotation. In some circumstances, there may be a limited space between the anterior surface of lens support structure 105 and the posterior surface of iris 10 . To reduce the risk of iris damage or pupil blockage, it may be advantageous to secure the IOL 110 on or behind the plane of the lens support structure 105. In addition, fixing the optic while improving the predictability of the refractive position makes preoperative lens selection calculations more accurate.

To facilitate the use of optical capture technology, lens support structure 105 may allow a surgeon to pass IOL 110 through aperture 115 of device 100 . Hole 115 may have a diameter similar to that of a typical IOL optic, for example at least 5.5 mm or 6.0 mm. In this situation, the surgeon may pass the IOL 110 through the hole 115 with a force parallel to the optical axis or by slightly tilting the IOL 110 so that the IOL 110 passes easily through the hole 115 . Hole 115 is greater than 5 mm, for example 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm, 9.0 mm, 9.5 mm, and 10.0 mm, and up to about 15 mm and any in between. It can have an inner diameter that is the value of

Alternatively, device 100 may incorporate a feature that temporarily enlarges the diameter of aperture 115 to allow IOL 110 to pass through aperture 115 . The support portion 105 may have discontinuous outer and inner walls such that the support structure 105 forms a split-ring with a gap between the distal ends of the ring. In this implementation, the inner diameter of hole 115 can be varied depending on whether the distal ends of the rings are compressed towards each other or flared. In other implementations, the outer circumferential wall may be completely ring-shaped or continuous in circumference and the inner circumferential wall defining aperture 115 may be discontinuous or continuous. A single hole may have a continuous inner circumference without any gaps, grooves or channels. Alternatively, a single hole may have a discontinuous inner circumference. 5 shows an implementation of device 100 having one or more slits 113 formed in interior wall 109 defining aperture 115 . The device 100 may include more than a single slit 113 , for example from 2 to 40 slits 113 in the inner wall 109 located circumferentially around the hole 115 . Slit 113 may preferably be of sufficient length to extend 0.25 mm-2.0 mm radially outward from the inner diameter of hole 115, thereby increasing the flexibility of support structure 105. IOL 110 may pass through flexible lens support structure 105 . Alternatively, device 100 may incorporate one or more deflectable flaps 116 molded into lens support structure 105 (see FIG. 6 ). Device 100 may include more than a single deflectable flap 116, for example 2 to 40 flaps 116 that deflect and allow IOL 110 to pass through aperture 115 under sufficient force applied by a surgeon. can include Alternatively, the inner wall 109 may have a brush-like structure that deflects and allows the IOL 110 to pass under sufficient force applied by the surgeon. In another implementation, the cross-sectional thickness profile of lens support structure 105 may taper toward aperture 115 . The outer circumference of the lens support structure 105 near the outer wall 111 has a greater thickness than the thickness of the inner circumference of the lens support structure 105 near the inner wall 109 (e.g., the anterior chamber when the device is positioned within the eye). -thickness measured posteriorly). Thus, the centralmost portion of the lens support structure 105 (i.e., the inner wall 109) allows the IOL 110 to pass through the aperture 115 and reduce the deflecting of the inner wall 109 when placed under sufficient force. It will have greater flexibility due to the reduced thickness. Despite the greater flexibility near the inner wall 109 due to the slit 113, the flap 116 or the reduced thickness, the lens support structure 105 has the IOL (which rests on the anterior surface of the lens support 105). 110) or have sufficient strength to support the IOL partially or completely behind the lens support 105.

7A and 7B illustrate various anchoring arms 120 having distal scaffolds or anchors 125 . Anchor 125 may be coupled to or positioned at the outer end of anchoring arm 120 . These geometries are easily externalized by the surgeon and designed to stabilize the tension of the device over its useful life. Anchor 125 may have a generally low profile and may have a geometry (eg, rounded) designed to limit conjunctival erosion and eyelid irritation. The distal end of the fixation arm 120 may have an anchor 125 configured to be positioned outside the sclera 20 to secure the lens support structure 105 and prevent centripetal slippage. The geometry of the anchor 125 allows a surgeon to pass the anchor 125 through a puncture or incision in the sclera 20 using forceps, trocars or other surgical instruments. The lasso device for anchor extraction is described in more detail below. Anchor 125 may preferentially pass through sclera 20 in a nail head, T-bar, multi-prong shape, or in a first direction when arm 120 is placed in tension expected throughout the life of the device. It may have a geometry similar to any other geometry capable of resisting being pulled in the insertion direction to maintain an external position. Anchor 125 is designed to have a profile and geometry that does not cause irritation to the eyelid or conjunctiva over the useful life of device 100 . Thus, a preferred geometry would have a minimum thickness profile with smooth, rounded and/or tapered edges. Anchor 125 may have a substantially constant thickness or may have a varying thickness over its length as described in more detail below.

The anchors 125 described herein are configured to easily externalize and resist re-internalization following externalization. The anchor may be designed to be gripped using an ophthalmic tool (eg 23, 25 or 27 gauge). A geometry that is ideal for gripping with an ophthalmic instrument may not necessarily be ideal for rigid fixation. 8A-8C illustrate additional geometries of anchors 125 with variations in thickness, width and/or height. Anchor 125 may include a central portion 1255 and one or more grippable portions 1257 at the periphery of the central portion. The central portion 1255 can be arranged to overlie the wound (sclera incision) into which the anchor 125 is inserted, and the grippable portion 1257 is arranged immediately adjacent to the wound. The central portion 1255 can have an increased thickness, height, and/or width compared to the grippable portion 1257 at the periphery. The increased thickness, height, and/or width of the central portion 1255 can add bulk to the area above the wound thereby reducing the likelihood that tension on the anchoring arm will pull the anchor 125 back through the wound. there is. The central portion 1255 of the anchor 125 may have a thickness Tc along the longitudinal axis L of the arm 120 greater than the thickness Tg of the grippable portion 1257 . For example, the thickness Tc may be about 1.2 times to about 5.0 times the thickness Tg of the grippable portion 1257 . In other implementations, the central portion 1255 can have a width or height that is about 1.2 to 5.0 times the width or height of the grippable portion 1257 . The geometry of the areas of greater bulk is designed to resist deformation under tensile forces associated with normal use of the device. The bulkier central portion 1255 can be folded inward to fold over the distal end of the arm 120 to which it is attached during externalization. When the arm 120 is placed in tension, the bulkier central portion 1255 cannot be folded onto itself from the distal end of the arm 120, which causes the externalized anchor 125 to pull back through the wound. prevent losing Thus, the central portion 1255 can be pulled through the wound in a first direction (outward from the eye) despite its greater bulk, but in a second opposite direction (inward toward the eye) through the wound due to its greater bulk. ) is prevented from being pulled.

The grippable portion 1257 can be any of a variety of shapes, including, for example, an oval, rectangular, star-shaped pattern, or other shape or geometry that improves the grip of the grippable portion 1257 compared to the central portion 1255. may include the The grippable portion 1257 can have thin narrow tabs extending from the central portion 1255 . Each anchor 125 may include 1, 2, 3, 4, 5, 6 or more grippable portions 1257 to allow a user to grip the anchor regardless of the shape of the device.

In some implementations, each anchoring arm 120 may have more than a single anchor 125 . 9 illustrates an implementation of the device 100 having three anchoring arms 120, each anchoring arm having a first anchor 125a on the distal end and a second anchor located inside the first anchor 125a. (125b). The second anchor 125b may further fix the lens support structure 105 by preventing centrifugal slippage. Alternatively, the second anchor 125b may be externalized through the sclera 20 such that the second anchor 125b also holds the device 100 in place. In this situation, the surgeon has the option of trimming any material of the fixation arm 120 positioned around the second anchor 125b (eg, the first anchor 125a). This multi-anchor system allows the surgeon to size the device 100 relative to the patient's eye during surgery. Each anchoring arm 120 may include a plurality of anchors 125 that may be positioned along the length of the anchoring arm 120 . The plurality of anchors 125 may include 2, 3, 4, 5 or more anchors 125 evenly spaced along its length. As the fixation arm 120 is externalized through the sclera, the length of the fixation arm 120 can also be “customized” according to the number of anchors 125 being externalized. The surgeon may externalize as many anchors 125 as necessary to center the device 100. Excess material of the fixation arm 120 and anchor 125 around the external anchor 125 closest to the sclera 20 may be removed by trimming or the like. 9 illustrates two anchors 125a, 125b with different external dimensions, the inner anchor 125b being narrower than the outermost anchor 125a. It should be understood that the plurality of anchors 125 may also have the same dimensions and need not differ in size. Anchor 125 may also have a geometry that improves passage through the sclera in a first direction but impairs passage through the sclera in a second, opposite direction. For example, FIG. 9 illustrates the square edge of anchor 125 . However, anchor 125 may have a square edge on the inner facing surface and a smooth tapered edge on the outer facing surface to facilitate passage through the sclera in an outward direction.

The fixation arm 120 extending into the eye wall can be difficult to maneuver as it can be blocked from the field of view by the surrounding iris 10 , limbus and sclera 20 . As noted above, one or more of the anchoring arms 120 may be biased inward toward a collapsed configuration. Each stationary arm 120 may initially extend outwardly in an orthogonal direction from the support structure 105, after which the distal end of the stationary arm 120 is connected to the stationary arm 120, the support structure 105, or the support. It may be bent or folded forward (or backward) to be positioned over at least a portion of a central aperture 115 extending through the structure 105 . At least a portion of the bent fixation arm (ie the distal end and/or anchor 125) can be more easily visualized through the dilated pupil and the visualization is not obstructed by the opaque iris 10 (see FIG. 13). This inward (centripetal) deflection also allows the bent anchoring arm 120 to be safely gripped and manipulated during device implantation. Each fixation arm 120 of device 100 may have an inward bias toward a folded configuration or only a selection of fixation arms 120 may have an inward bias (e.g., one, two, up to all less than the fixed arm (120).

Device 100 can be produced without inward deflection and inward deflection settings using manual manipulation of the device. Manipulation may be performed by the manufacturer or by a surgeon. The goal of the manipulation is to temporarily position at least a portion of the fixation arm 120 so that it can be easily visualized through the dilated pupil during implantation. Manipulation may involve stitching two or more anchoring arms 120 together. The sutures may be removed once the surgeon is ready to individually manipulate the fixation arms 120 within the eye. The device 100 structure may incorporate one or more features that allow the fixation arm 120 to temporarily engage the lens support structure 105 in a manner that aids visualization of the fixation arm 120 . For example, FIG. 9 shows that the interior wall 109 defining the central aperture 115 may include one or more notches 117 that may be used to temporarily hold the anchoring arm 120 in an inwardly biased position. shows The shape of each notch 117 is complementary to the shape of the anchoring arm 120 such that at least a portion of the anchoring arm(s) 120 can be received within the notch 117 . A manufacturer or surgeon may fold, twist or otherwise manipulate fixation arm 120 into notch 117 . After insertion into the eye, the surgeon may proceed to disengage the fixation arm 120 from the notch 117 and externalize the fixation arm 120 through the sclera. A notch 117 is shown on the inner diameter or inner wall 109 in FIG. 9 . However, notch 117 may be on other surfaces of device 100, including a peripheral surface (eg, exterior wall 111), anterior surface, or posterior surface of lens support structure 105.

The fixation arm 120 may also be molded to incorporate a bend or bend between its starting point with the lens support structure 105 and the distal anchor 125 (FIGS. 10-12, 17B-17E, 19A). 20a, 21a and 21b, 22a and 22b, 23a and 23b, 24a to 24f, 25a to 25c, 26a to 26e and 27). The bent fixation arm(s) 120 may be biased towards a collapsed configuration. For example, one or more of the fixing arms 120 may be bent 90 degrees to 270 degrees from their starting point with the lens support structure 105 in radial and centripetal directions. Thus, the distal end of the bent fixing arm 120 lies in a different plane than the plane of the lens support structure 105 . When at rest prior to placement on the eye, the distal end of at least a first fixation arm 120 of the plurality of fixation arms 120 is interposed between its starting point with the lens support structure and its distal end forming a bent arm. A bend can be incorporated. The bent arm may extend at least a first distance from its starting point orthogonal to the lens support structure 105 . The bent arm may be bent upward (forward) at least another distance from the plane of the lens support structure 105 . The bent arm 120 can then be bent back towards its starting point or towards the central axis CA of the device. This may cause the distal end of the bent arm 120 to lie in a different plane than the plane of the lens support structure 105 . A bend or bend of the arm 120 may project outwardly from the central axis CA and away from both the starting point 103 and the distal end 102 of the arm. The distal portion of the transscleral anchor 125 and/or anchoring arm 120 may be positioned over or in front of at least a portion of the lens support structure 105 or positioned over at least a portion of the central aperture 115 . Alternatively, the bent arm(s) 120 may be bent downward (rearwardly) from the plane of the lens support structure 105 by at least a distance and the distal end of the transsclera anchor 125 or fixation arm 120. The portion may be located under or behind at least a portion of the lens support structure 105 and/or below or behind at least a portion of the central aperture 115 . A folded configuration (whether arm 120 is bent forward or backward) is such that at least a portion of bent anchoring arm 120, such as the distal end of bent anchoring arm 120 and/or its anchor 125, is bent. Allows visualization through the pupil, unobstructed by the opaque iris. Only one arm 120 of the fixation arms 120, two arms 120 of the fixation arms 120, or all of the fixation arms 120 may incorporate a bend.

Once the device is positioned and secured within the eye, the fixation arm 120 is placed in tension such that the bent arm unfolds from its collapsed configuration and is no longer bent. The distal end of arm 120 is urged from a rest state in which arm 120 is in a collapsed configuration to urge the bent stationary arm into a straight or extended configuration.

The bend in the folded configuration can be a gradual smooth bend with a radius of curvature or can be bent to form one or more discrete angles along the length of arm 120 . The bend may be rigid enough to avoid protruding too far forward while still being able to be relatively easily unfolded or placed in an unfolded configuration without imposing excessive stress on the lens support structure 105 . The inwardly deflected geometry may have a bend with a radius of curvature of from about 0.10 mm to about 2.5 mm on the inner bend (front facing side) and a radius of curvature of from about 0.6 mm to about 3.0 mm on the outer bend (back facing side). In an implementation, the distal end of the inwardly biased fixation arm may be spaced apart from the lens support structure 105 forming the gap G (see FIG. 17B). The gap (G) may be about 0.2 mm up to about 2.5 mm. In an implementation, the deflected fixation arm 120 is curved to a full radius of 180 degrees and has a radius of curvature of about 0.63 mm at the inner bend and about 1.13 mm at the outer bend such that the lens support structure 105 and the deflected fixation arm are spaced apart by about 1.25 mm. It has an inwardly deflected geometry with a radius of curvature of The start point of the bend (near the start point 103 with the lens support structure 105) and the end point of the bend (near the end 102 at the transscleral anchor 125) are multiple such that the bend changes over the length of the fixation arm 120. can have a radius of The curvature of the biased fixation arm 120 may have an average curvature at the inner curvature of about 0.15 mm to about 2 mm.

The bent anchoring arm 120 is visible through the pupil when in an unstressed (resting) state after implantation and prior to anchoring to the scleral wall (see FIG. 13 ). This visibility allows the surgeon to easily engage anchor 125 . When the surgeon engages the fixation arm 120 by gripping the main body of the fixation arm 120 or the anchor 125, the surgeon rests the fixation arm 120 in a manner substantially flush with the lens support structure 105. It can be unfolded from a folded configuration. This anchoring arm 120 may be flexible such that in the deployed state the stress stored in the material does not impart torsional or tensile forces to the lens support structure 105 in a manner that impairs device functionality. The fixing arm(s) 120 may be molded to have a 90-270 degree turn in the tangential and centripetal directions from the lens support starting point (see Figs. 23A and 23B). Fixation arm(s) 120 may incorporate a resilient material or deformable hinge to facilitate this manipulation without substantially changing the geometry of the lens support structure 105 . The distal end 102 of the fixation arm 120 is shown in FIGS. 10 and 11 when the fixation arm 120 is bent 180 degrees backward toward its starting point with the lens support structure 105. As described above, it may have a length such that it can be positioned over at least a portion of the lens support structure 105 . Each fixation arm 120 of device 100 may have a bend or only a selection of fixation arms 120 may have a bend (e.g., one, two, at most less than all fixation arms 120). . 10 and 11 show that two of the fixing arms 120 have bends and one fixing arm is substantially coplanar with the plane of the lens support structure 105 .

One or more of the anchoring arms 120 of the device described herein can be manufactured to have a non-planar geometry in a resting state, and once the device 100 is implanted, it is anchored through the pupil prior to externalization of anchors 125. At least a portion of the arm 120 may be biased toward a collapsed configuration that makes it easier to see. The fixation arm 120 with this configuration can be more easily gripped and manipulated by the user and pressed into a deployed configuration for a sutureless fixation. The fixation arm 120, which is manufactured to have a deflection in the resting state or to be curved or bendable in the resting state, includes the fixation arm 120 having its shape when the device 100 is out of the eye and ready for implantation. In some implementations, anchoring arm 120 may assume a curved, folded, or bent configuration after implantation within the eye (eg, posterior chamber) but prior to anchor anchorage. For example, the one or more anchoring arms 120 have a first shape outside the eyeball, assume a curved shape upon implantation into the eyeball, different from the shape of the arm 120 prior to implantation into the eyeball, and anchor 125 It can be formed of a material that can be stretched in a substantially straight line shape upon externalization.

The fixation arm 120, which has a bias toward a folded or curved shape (eg, with a bend along the length between the beginning portion 103 and the distal end 102), is visualized through the pupil, grasped, and , can be manually deployed and/or extended to secure the anchor 125 of the arm 120 to the transsclera. The configuration and/or radius of curvature of the bend, bend or fold, as well as the directional orientation of the bend, bend or fold, is at least part of the fixation arm 120 (e.g., anchor 125 and/or anchor 125). ) can vary as long as the distal end coupled to ) is visible to the user through the diameter of the patient's pupil, preferably the patient's dilated pupil. In some implementations, this means that at least a portion of the fixation arm 120 is positioned over at least a portion of the lens support structure 105 and radially inward of the outer wall 111 thereof. The distance a portion of arm 120 extends radially inward of outer wall 111 may vary. This portion may extend to be above a position adjacent to the exterior wall 111 but not above the exterior wall 111 in a central axis (CA) orientation extending anteriorly-rearward through the central opening 115 . In this implementation, the distance between the central axis CA of the device and the elongated portion is greater than the distance between the central axis CA of the device and the outer wall 111 . The portion may extend to be above the outer wall 111 . In this implementation, the distance between the central axis CA of the device and the part is equal to the distance between the central axis CA of the device and the outer wall 111 . This portion may extend to be above a radially inward position relative to the outer wall 111 . In this implementation, the distance between the central axis CA of the device and the part is smaller than the distance between the central axis CA of the device and the outer wall 111 . The portion may extend to be above the central opening 115 . In this implementation, the distance between the part and the central axis CA of the device is less than the distance between the central axis CA of the device and the inner wall 109 defining the central opening 115 .

A portion of the anchoring arm (eg, the distal end and/or anchor 125 ) may be positioned over a portion of the lens support structure 105 and simultaneously also over a portion of the central aperture 115 . For example, the anchors 125 are dimensioned such that at least a portion of the anchors 125 is positioned over at least a portion of the lens support structure 105 and another portion of the anchors 125 is positioned over at least a portion of the central opening 115. can have

The fixation arm 120 biased toward a curved configuration may be curved towards an interior or central portion of the device, including but not limited to the actual center or central axis (CA) of the device. The center of the device 100 is the center of the circle formed by the center hole 115 (if the center hole 115 is circular). A central axis CA of the device extends through the center of the circle in a forward-backward direction (ie, a top-bottom direction). When the central aperture 115 is substantially non-circular, the center of the device is the center of symmetry of the central aperture 115 along the central axis CA extending in the anterior-rear direction. A fixed arm deflected in a folded or curved configuration such that the anchor extends toward the center of the device or the central axis CA of the device, such that the axis through the anchor of the arm intersects the actual center or intersects the central axis CA of the device. don't need anything "Toward the center" or "toward the central axis" in reference to an inwardly biased fixation arm means that the distal end of the fixation arm is part of the device, as opposed to the distal end of a straight fixation arm which extends in a generally outward direction away from the lens support structure. and an arm having a curvature so as to extend backwards in a generally inward direction towards the . The curved fixation arm can be biased toward any central portion of the device and need not point directly to the actual center of the device. The curved fixation arm may be inclined with respect to the actual center.

22a and 22b and 23a and 23b illustrate implementations of a device in which at least a portion of the anchoring arm extends backwards toward the center of the device. 22A shows a device 100 having a lens support structure 105 and three fixing arms 120 . The two fixed arms 120a, 120b are deflected into a folded configuration where the bend B is between the start 103 and the distal end 102 of the arm. The third fixing arm 120c is substantially straight and does not have a bend B between its starting point 103 and its distal end 102 so as to extend substantially orthogonal to the lens support structure 105 along a single axis. don't An anchor 125 of each fixing arm 120a, 120b protrudes backward toward the center of the device. The anchors 125 of the fixing arms 120a, 120b have at least a first portion overlapping at least a portion of the lens support structure 105 and/or at least a second portion overlapping at least a portion of the central opening 115 ( see Figure 22a). Each arm 120a, 120b has an axis illustrating the direction in which the anchor 125 protrudes away from the bend B between the start point 103 of the arm and the distal end 102 of the arm and towards the center of the device. ) can be created through the anchor 125. Axis L1 and axis L2 do not intersect central axis CA. Figure 22b shows a similar device 100 with two fixed arms 120a, 120b biased in a folded configuration. Each fixed arm has a bend B between the start point 103 and the distal end 102 of the arms 120a and 120b. An anchor 125 of each fixing arm 120a, 120b extends back towards the center of the device. Axis L1 and axis L2 intersect central axis CA. Thus, the arm may be biased toward a collapsed configuration in which the anchor protrudes back towards the center of the device, but need not extend along the central axis CA or an axis that intersects the actual center of the device.

When a stationary arm is described as being "folded" or "bent" or "curved" or having a "collapsed" or "bent" or "curved" configuration, the The angle of the fixing arm can be changed gradually and uniformly, or it can be changed more sharply or abruptly to form an angle. The folded configuration describes the inward deflection of the fixation arm at rest or prior to implantation, in which the fixation arm extends outwardly from the support structure along the first axis and curves forward or rearward relative to the plane of the support structure back toward the central portion of the device. can do. Upon implantation, the support structure of the device is configured to lie substantially parallel to the Z-plane (vertical plane) of the eye. The folded configuration is such that the anchoring arms are bent away from this plane of the support structure (eg, in the transverse plane) as shown in FIGS. It may include geometry to allow it to be positioned anteriorly (eg, over itself, the lens support structure, and/or the central aperture). A folded configuration need not imply that the fixing arm parts overlap each other and are also in contact with each other. Preferably, the parts of the fixing arm are spaced apart from each other by a distance, the distance being along the central axis CA of the device. Also, a folded configuration need not imply a creased or sharply angled fold. A folded configuration may mean that there is a radius of curvature between the starting point of the anchoring arm and the distal end of the anchoring arm in the support structure.

The folded configuration may also include a fixation arm that curves within the plane of the lens support structure rather than away from the plane of the lens support structure. 23A and 23B illustrate another implementation of a device 100 having a lens support structure 105 and three fixation arms 120 . The two fixed arms 120a, 120b are deflected into a folded configuration where the bend B is between the start 103 and the distal end 102 of the arm. The third fixing arm 120c is substantially straight and does not have a bend B between its starting point 103 and its distal end 102 so as to extend substantially orthogonal to the lens support structure 105 along its axis. . An anchor 125 of the straight fixed arm 120c protrudes outward along the axis of the arm and away from the center of the device. In contrast, the anchors 125 of each of the fixing arms 120a and 120b protrude inward from the bent portion B of the arm. The anchors 125 remain substantially in the same plane as the plane of the lens support structure (see FIG. 23B). Each bent arm 120a has an axis illustrating the direction in which the anchor 125 protrudes away from the bend B between the start point 103 of the arm and the distal end 102 of the arm and toward the center of the device. , 120b) can be written through the anchor 125. The anchoring arms 120a, 120b biased towards the folded configuration have anchors 125 protruding towards the center of the device. Axes L1 and L2 may intersect central axis CA, but need not intersect. Axis L1 and L2 shown in FIG. 23A extend toward the center but do not intersect the central axis CA.

The portion of the arm 120 positioned over at least a portion of the support structure 105 may include a portion positioned radially inwardly as well as over the outer wall 110 of the support structure 105 . The portion of arm 120 positioned over at least a portion of support structure 105 may include a portion positioned radially inwardly and above central opening 115 . In this case, "radially inward" need not mean within the same plane. Preferably, a portion of the arm 120 is positioned over a portion of the support structure in a plane different from that of the support structure. A portion of anchoring arm 120 (eg, anchor 125 and/or distal end 102 ) may be forward or rearward of lens support structure 105 at a diameter median to the outer circumference of lens support structure 105 . can end in This portion may be positioned over the portion of the lens support structure about the central axis CA of the device that extends anteriorly-rearward through the central opening 115 . Where a portion of the fixation arm 120 is described as being over a portion of the lens support structure, a portion of the fixation arm 120 may also be over the central opening 115 defined by the lens support structure 105 .

Where a portion of arm 120 is described herein as being “above” another portion of device 100 (e.g., itself, lens support structure 105, and/or central aperture 115) , a portion of arm 120 can generally overlap in space with that portion of the device and does not require a specific orientation relative to the retina. Thus, "above" may be used herein generically to refer to the overlap of the space surrounding the device, and it is not necessary that the spatial overlap be in a generally forward direction relative to the retina. A portion described as being “above” another portion may be positioned behind it relative to the retina during use. The deflected arm 120 in a folded configuration may only be referred to as “above” or “overlapping” other parts of the device, but may also be positioned “below” or “behind” other parts of the device relative to the retina during use. . For simplicity, each alternative may not be repeated in each instance throughout this disclosure. The arm may be curved to position at least a portion of the arm over a front facing portion of the device such that the portion generally arcs over the device along a central axis CA. The arm may be curved to position at least a portion of the arm over a rear facing portion of the device such that the portion generally arcs down the device along the central axis CA. The arm can be curved to place at least a portion of the arm in the same plane, so that it is neither over the front facing part nor over the back facing part of the device. Any of a variety of configurations of the fixation arm are contemplated herein such that at least a portion of the arm is visible through the dilated pupil. The mechanism may be varied by unfolding the bent fixation arm 120 biased towards the collapsed configuration to assume a straight configuration. Arms can be extended mechanically, electromagnetically and/or thermally.

In some implementations, the stationary arm 120 can be mechanically stretched along a single axis of the arm. The stationary arm 120 at rest need not be deflected into a folded configuration that has bends or curves. For example, stationary arm 120 may be deflected into a collapsed configuration where arm 120 is longitudinally compressed along a single axis. Arm 120 extends along a single axis between its beginning portion 103 and its distal end portion 102 orthogonally outward from the lens support structure. The length of the arm 120 in the collapsed configuration may be shorter between the beginning portion 103 and the distal end 102 such that the anchor 125 of the arm 120 is longer within a smaller diameter than in the unfolded configuration. is located in the center Once the device is implanted within the eye, however prior to externalization of anchor 125, arm 120 may be telescoped outward to extend its length so that the arm can be externalized. Mechanical unfolding by telescoping can result from the nested components of the arms 120 sliding over each other to provide a longer length when unfolded or a shorter length when folded. Mechanical unfolding by telescoping can also result from a single elastic component configured to fold on itself for shorter lengths for visualization through the pupil and to unfold itself for longer lengths during externalization.

In some implementations, the anchoring arm 120 can be unfolded or thermally collapsed. For example, the fixation arm 120 may be in a first shape (folded or straight) at room temperature and change to a second shape at or near body temperature (heated to 35°C). It can also be effected by chemical means (eg, hydration) or mechanical means (cutting restrictive features).

The fixing arm 120 may be made of an elastic or non-elastic material. For example, the fixing arm 120 may be formed of an inelastic material and may have a three-dimensional shape that provides elasticity. The three-dimensional shape may vary as described elsewhere herein, including a C-shape, Z-shape, S-shape, or other three-dimensional shape. The anchoring arm 120 provides sufficient support to hold the IOL 110 or other device without exerting excessive force on the scleral tissue. An optimal design will have a wide range of operable tension and stability to satisfy both parameters in different sized eyes and with different locations of incisions. One means of modifying the stationary arm design is to incorporate a spring-like structure. These may include traditional compression-based haptic designs such as J-loop, C-loop, closed-loop, Kellman haptic, plate haptic, or other haptic designs common to IOLs. Alternatively, device 100 may incorporate tension-based haptics, such as simple linear elastic cords. Alternatively, the tension design may be modified with V-shaped, Z-shaped or S-shaped features to reduce the tensile resistance of the anchoring arm 120 .

The fixation arm 120 may have a texture or feature that allows it to be pulled through the sclera in one direction, but there is resistance in the opposite direction to minimize the possibility of the fixation arm 120 slipping. The texture or feature may be provided by the material itself or designed into the anchoring arm 120 . For example, the anchoring arm 120 may be formed from a material that is barbed and integrated into the outer structure. In this way, the barbed internal structure can function as a barb while hiding the sharp edges normally associated with barbs. An example is a rigid plastic structure embedded in a soft elastomeric structure.

The stationary arm 120 may be formed of a flexible material that has a memory and is not malleable. The flexible material of the fixing arm 120 is polyurethane, hydrophobic acrylic, hydrophilic acrylic, nylon, polyimide, PVDF, natural polyisoprene, cis-1,4-polyisoprene natural rubber (NR), trans-1,4- Polyisoprene gutta-percha, synthetic polyisoprene (IR for isoprene rubber), polybutadiene (BR for butadiene rubber), chloroprene rubber (CR), polychloroprene, neoprene, vaperene, etc., butyl rubber (copolymer of isobutylene and isoprene , IIR), halogenated butyl rubber (chlorobutyl rubber: CIIR, bromobutyl rubber: BIIR), styrene-butadiene rubber (copolymer of styrene and butadiene, SBR), Buna N rubber hydrogenated nitrile rubber (HNBR) terban and jet Nitrile rubber (copolymer of butadiene and acrylonitrile, NBR), also called poly, EPM (ethylene propylene rubber, copolymer of ethylene and propylene) and EPDM rubber (ethylene propylene diene rubber, terpolymer of ethylene, propylene and diene components synthesis), epichlorohydrin rubber (ECO), polyacrylic rubber (ACM, ABR), silicone rubber (SI, Q, VMQ), fluorosilicone rubber (FVMQ), fluoroelastomer (FKM and FEPM), Viton, Technoflon ( Tecnoflon, Fluorel, Aflas and Dai-El, Perfluoroelastomer (FFKM) Tecnoflon PFR, Kalrez, Chemraz, Perlast, Polyether A variety of elastomers, including block amides (PEBA), chlorosulfonated polyethylene (CSM), (hypalon), ethylene-vinyl acetate (EVA), thermoplastic elastomers (TPE), resilin and elastin, polysulfide rubber, and elastofin Any of these may be included.

An arm 120 made of a flexible material that is formed into a shape can be bent out of the formed shape, but has memory to return to the formed shape. In other words, the flexible anchoring arm 120 can be flexed or unfolded from its collapsed configuration, but cannot be forced into a different shape held without anchoring fixation of some kind. For example, one or more of the flexible fixing arms 120 may be formed in a bent shape. For example, the arm may include a 180 degree bend from its starting point 103 with the support structure 105 to its distal end 102 near the anchor 125 . Arm 120 can maintain this bent shape when the device is at rest and no force is applied to arm 120 such that arm 120 is biased towards a folded configuration. In other words, the arm 120 in an undeflected state is bent. The bent anchor arm 120 can be bent from this bent shape to assume a straight or unfolded configuration such that the entire arm 120 is extended and positioned straight about the longitudinal axis L. When flexed into a straight shape, arm 120 deflects back to a bent or folded configuration. When the bending force applied to the fixed arm 120 is released, the arm 120 will return to its resting bent shape. However, in use, the fixation arm 120 is fixed to the scleral and the anchor 125 is positioned at the distal end 102 of the arm 120 positioned outside the sclera. Arm 120 is tensioned to maintain a straight shape.

In other implementations, the stationary arm 120 can be formed of or incorporate a material that is malleable such that the stationary arm 120 can be bent or formed into a specific shape. The malleable stationary arm 120 is formed from materials such as implant grade metals or plastics including gold, silver, platinum, stainless steel, nitinol, nickel, titanium, polypropylene, polyethylene, nylon, PVDF, polyimide, acetal and PEEK. It can be.

One or more anchoring arms 120 may have a Young's modulus that is less than about 1000 MPa, or less than about 500 MPa, or less than about 250 MPa, or less than about 100 MPa, or less than about 50 MPa, or less than about 25 MPa. One or more of the anchoring arms 120 may have a Young's modulus of less than about 20 MPa, for example from about 0.01 to about 1.0 MPa. Because the anchoring arm 120 is designed in tension to anchor the support structure 105 rather than having the spring force or more rigid penetration that barbs or other anchoring haptics can provide, it is very flexible. It is ductile and can apply very little force.

In some implementations, the anchoring arm 120 can have a length between the starting point 103 and the distal end 102 that are each between about 2 mm and about 6 mm. Each of the fixing arms 120 may have the same length. The length of the anchoring arm 120 extending through the sclera may have a thickness or width that is minimized to reduce the overall size of the wound through which the arm 120 extends. The maximum width of the transsclera portion of the fixation arm near the distal end 120 at which the anchor 125 is positioned may be less than or equal to about 2.0 mm, less than or equal to about 1.5 mm, less than or equal to about 1.0 mm, less than or equal to 0.75 mm, or less than or equal to 0.50 mm.

12 also shows an implementation of the device 100 having two fixed arms 120a, 120b with inward deflection and a third fixed arm 120c that is straight and has no inward deflection. Additionally, the third fixation arm 120c has a geometry that makes it less flexible than the other fixation arms 120a and 120b. The third fixation arm 120c may incorporate an area between the start point 103 and the distal end 102 which may be wider and have a higher cross-sectional area than the other two fixation arms 120a and 120b. 8B also shows the area of the fixation arm 120 that is wider. A width W1 of arm 120 near distal end 102 may be less than a width W2 of arm 120 away from distal end 102 of arm 120 . The width W2 of the arm 120 away from the distal end 102 may provide some bulk and stability while the width W1 near the distal end 102 defines the transscleral portion of the arm 120. can be minimized.

Each fixation arm 120a, 120b, 120c can be positioned one at a time during a surgical procedure. As described elsewhere herein, the leading anchor arm 120c may be of a straight configuration and the trailing anchor arms 120a and 120b may be curved (see FIGS. 17A-17D ). The weight of the device may cause the first implanted or proximal fixation arm 120c to bend after externalization such that the device 100 is tilted rearwardly toward the retina. In this scenario, the surgical surgeon may place the device in a more posterior position. However, this may increase the risk of tissue damage during surgery due to instrument manipulation near the retina. In some implementations, the leading anchor arm 120c may be mechanically and/or geometrically stiffened to reduce the likelihood of rearward drift. The tip fixing arm 120c may be made of a material that resists such deformation. The material can be any implant grade plastic or metal that can make the device cantilevered after externalization of the anchor 125 of the proximal fixation arm 120c. Suitable materials include, but are not limited to, PMMA, rigid silicone, nylon, hydrophilic and hydrophobic acrylics, PEEK, polyimide, stainless steel, titanium, nitinol, and the like. A stiffer material may be used to form the entire proximal arm 120c or just a portion of the proximal anchoring arm 120c. The tip fixing arm 120c may be formed of a softer material in which a more rigid material is embedded. In an implementation, the proximal anchoring arm 120c may include a mechanical reinforcement region 1205 between its starting point 103 in the support structure 105 and its distal end 102 coupled to the anchor 125 ( see Figure 17a). Area 1205 may be achieved by increasing the thickness of anchoring arm 120c or by embedding a rigid section of plastic into a softer material. 17A shows the increased thickness (arrow T) in the mechanical reinforcement region 1205 compared to the thickness of the arm near its starting point 103 (arrow O) with the support structure. Region 1205 may be spaced a distance from support 105 , for example close to or adjacent to anchor 125 . Region 1205 has an increased thickness designed specifically to reduce the likelihood of device 100 drifting backwards without affecting the ability of anchor 120 to externalize anchor 125 (FIGS. 17d). For example, the anchoring arm 120 may have a tapered thickness designed to limit deflection in the rearward direction. The tapered geometry may be thinnest near the scaffold anchor 125 and thicker in the center. The posterior surface of the anchor may serve to bias the device anteriorly relative to the eye. The angle of contact of the wound with the posterior surface of the fixation arm 120 may deflect the device 100 in a manner that reduces the substantial risk of rearward deflection of the fixation arm 120 . The extra bulk can further limit the device's deflection and proximity to the retina.

Transsclera fixation arm 120 and/or anchor 125 may have a photo-reactive or hydrogen-responsive element that aids in sizing or fixation of the fixation arm. By swelling or contracting a portion of the fixation arm, the geometry of the fixation arm can be expanded or contracted to adjust the length of the fixation arm intraoperatively or postoperatively. Alternatively, by extending the anchor after externalization of the anchoring arm, the anchor is more effective in providing secure anchoring while reducing the risk of slipping.

The cross anchor of the fixing arm can slide along the fixing arm 120 with little resistance. By adjusting the fixation arm 120 intraoperatively, the surgeon can size the device 100 specifically for a given patient. Custom sizing reduces the risk of slippage and tampering of the effective lens position. Once the fixing arm 120 is set to an appropriate tension, excess material can be removed by trimming or the like.

Device 100 can include a geometry or be made of a material that can serve as a drug delivery device, including a refillable drug delivery device. A rigidly fixed device accessible in the subconjunctival space provides an opportunity to deliver drugs to the posterior and anterior segments of the eye. Examples of therapeutic agents include one or more drugs to lower intraocular pressure (glaucoma medications), steroids, biologic agents such as anti-vascular endothelial growth factor (anti-VEGF), gene therapy, antibacterial, antiviral, chemotherapy, and non-steroidal agents. Sexual anti-inflammatory agents, particularly agents for the treatment of ocular or systemic diseases.

The device 100 may include a structure to which the IOL haptics 114 may be fixed. In some situations, IOL haptics 114 may be anchored within the sulcus. However, it may be advantageous to provide a location for haptic fixation within the device itself. The structure of device 100 may be one or more pockets on interior wall 109 of lens support structure 105 sized and shaped to receive IOL haptics 114 . Alternatively, the anterior or posterior surface of device 100 may include slots or clasps that can receive and secure IOL haptics 114 in place. Lens support structure 105 may have one or more apertures through which IOL haptics 114 may pass. Alternatively, the haptic geometry can be designed such that the IOL haptics 114 can be wrapped around one or more of the fixation arms 120 . Fixation arm 120 may also have a hole through which an IOL haptic 114 may pass.

Device 100 may be designed to host any type of intraocular lens 110 with any haptic design and any optic design. Device 100 may be designed to fit a particular IOL design with a geometry specifically designed to mate with lens support structure 105 . The design may be particularly adapted to allow interchangeable lenses. The lens support structure 105 may be made of an integral lens 110 that provides refractive correction. Corrections may include, but are not limited to, monofocal, extended depth of focus, accommodating, adjustable illumination, multipiece/interchangeable or multifocal IOL optics.

The devices described herein may be used with IOLs having any of a variety of conventional designs, including integral designs as well as multi-piece designs. The IOL 110 may include a central optic 112 and two haptics 114 (eg, FIGS. 19B-19C, 20B and 20C, 24B, 24C, 24F, 25B , see FIGS. 25c, 26b, 26c, and 26e). Haptic 114 may be a conventional open loop haptic, such as a C-loop, J-loop, modified J-loop, or other haptics. The IOL 110 may be positioned above (or below) the central aperture 115 of the device such that a central axis (CA) extending anteriorly-posteriorly through the central aperture 115 is aligned with the optics of the IOL 110. (112). Haptics 114 of IOL 110 may protrude upward or forward from (or towards lens support structure if positioned below) lens support structure 105 as described elsewhere herein. An integral IOL may have open-loop haptics similar to a conventional three-piece IOL. An integral IOL may incorporate monobloc plate style haptics. If the device is one type of IOL (e.g., the multi-piece IOL shown in FIGS. 19B-19C and 20B-20C or the FIGS. and 26E), and 26E), it should be understood that other types of IOLs may be mated with the device. The devices described herein can be used with any type of IOL described elsewhere herein, including integral designs as well as multi-piece. Likewise, the haptics of the IOL can be any of a variety of configurations.

The lens support structure 105 may have a geometry configured to mate with the periphery of the IOL or one or more haptics of the IOL. The geometry may include a concavity, recess, channel or groove forming at least a portion of the inner circumference of the lens support structure.

24A-24F, 25A-25C, and 26A-26E illustrate various implementations of a device configured to mate with an IOL such that at least a portion of the IOL is covered by at least a portion of an interior surface of the device.

24A-24F illustrate an implementation of a device 2100 having a lens support structure 2105 , a central hole 2115 , and a plurality of fixation arms 2120 . The central aperture 2115 may be defined by an inner periphery or inner wall 2109 of the lens support structure 2105 . The central hole 2115 may be circular, but the periphery or outer wall 2111 of the lens support structure 2105 may be non-circular. As described elsewhere herein, the outer circumference of the lens support structure 2105 can be circular, non-circular, oval, elliptical, rounded rectangle (FIGS. 25A-25C), rounded triangle (FIGS. 26A-26E), etc. It may have any of a variety of shapes, including. The lens support structure 2105 can support the IOL 110 in place of, for example, the capsular bag of the natural lens. Device 2100 includes one or more leaflets or awnings 2126 positioned over an anterior facing surface of lens support structure 2105 to form one or more recesses 2104 into which at least a portion of IOL 110 may be positioned. can do. Recess 2104 may at least partially surround central aperture 2115 and may be sized to receive at least a portion of an IOL such as haptic 114 . 24B , 24C and 24F show IOL 110 engaged with device 2100 . Optic 112 of IOL 110 is positioned over central aperture 2115 and the peripheral region of the posterior facing surface of optic 112 is positioned relative to the anterior facing surface of lens support structure 2105 . Each haptic 114 of the IOL 110 may be positioned substantially within a respective recess 2104 and most of the optics 112 of the IOL 110 remain outside the recess 2104 . Recess 2104 may be defined by the front facing surface of lens support structure 2105 and a protruding leaflet or awning 2126 . The volume of the recess 2104 formed by the space between the front facing surface of the lens support structure 2105 and the rear facing surface of the awning 2126 is the central axis CA of the opening 2115 as well as the anterior-rear depth. sufficient to accommodate each of the haptics 114 at both distances from Shade 2126 may have a smooth geometry and once positioned on device 2100 may serve to protect the iris from any sharp edges of the IOL. In addition, the central facing surface of awning 2126 (facing toward the central axis CA of device 2100) may further serve to provide a surface on which haptics 114 may abut. These surfaces can provide counter pressure to the haptics and thereby help center the IOL 110 to the device 2100. Shade 2126 can also limit Z-axis movement of haptic 114 and help secure IOL 110 to device 2100 . Stable fixation of IOLs, including integral IOLs, allows the use of IOLs that require tight centering tolerances (e.g., torics, multifocal lenses, extended depth of focus (EDOF) IOLs, and accommodating IOLs) let it

IOL 110 may be positioned within device 2100 prior to implantation into the eye or after implantation into the eye. Similarly, IOL 110 can be removed from device 2100 and replaced after surgery.

24A-24F illustrate an implementation of a device 2100 having a substantially oval-shaped outer circumference 2111 having a major axis and a minor axis. Thus, the inner circumference 2109 can define a circular central hole 2115 and the outer circumference 2111 can define a non-circular shape. The recesses 2104 formed by the visor 2126 are positioned opposite each other about their long axis such that the span of the IOL 110 haptic 114 can be received within the recess 2104.

25A-25C illustrate another implementation of a device 2100 having a circular central hole 2115 and a non-circular periphery 2111 . The non-circular perimeter 2111 of FIGS. 25A-25C is a rounded rectangular shape with two substantially flat elongated sides 2108 and two substantially round short sides or lobes 2107 . Recesses 2104 formed by shading 2126 may protrude above the anterior facing surface of lens support structure 2105, and thus are located generally opposite each other along the long axis of the rectangle and provide IOL 110 haptics 114. are spaced to accommodate the span of For example, sunshade 2126 protrudes over the front facing surface of lens support structure 2105 on the short side of the rounded rectangle (i.e., at the location of lobe 2107) and is recessed along long side 2108 ( 2104) can accommodate the span of the IOL in between.

Three fixation arms 2120 may be coupled to the lens support structure 2105 . At least one of the anchoring arms 2120a, 2120b may be biased into a collapsed configuration as described elsewhere herein. One anchoring arm 2120c is single orthogonal to the lens support structure 2105 such that its distal end 2102 coupled to the anchor 2125 protrudes outwardly away from the central axis CA of the aperture 2115. It may be a fixed end arm extending along an axis. The proximal fixation arm 2120c can be coupled to the lens support structure 2105 at the position of the lobe 2107, and the other fixation arms 2120a, 2120b are spaced apart from the lobe 2107 of the proximal fixation arm, for example opposite. It can be coupled to side 2108 such that opposing lobes 2107 project outwardly between arms 2120a and 2120b (see FIGS. 25A and 25B ).

26A-26E illustrate another implementation of a device 2100 having a circular central hole 2115 and a non-circular periphery 2111 . The non-circular shape of the periphery 2111 may be a rounded triangular shape with a plurality of lobes 2107 protruding outward from a plurality of sides 2108 as described elsewhere herein. Each of the three fixation arms 2120 may extend outwardly from a respective one of the plurality of sides 2108 . Shades 2126 may protrude over the front facing surface of lens support structure 2105 to be positioned generally opposite each other. The first awning 2126 can be located, for example, on the side 2108 near the starting point 2103 of the tip fixing arm 2120c and the second shading 2126 is the other two fixing arms 2120a, 2120b. lobe 2107 between them (see FIGS. 26A-26B). The arrangement of the awnings 2126 relative to each other is such that the first awning 2126 can be positioned on the lobe 2107 adjacent to the starting point 2103 of the leading fixing arm 2120c and the second shading 2126 is a curved fixture. One of the arms 2120a, 2102b can be rotated so that it can be positioned on the side 2108 near the starting point 2103. Regardless of the orientation, the span of the recess 2104 defined by the sunshade 2126 and the lens support structure 2105 is sufficient to accommodate the span of the IOL haptic 114 therebetween (see FIG. 26C ).

The central aperture 2115 allows the optic 112 of the IOL to pass over the anterior-facing surface of the lens support structure 2105 without the optic 112 sliding through its diameter (eg, about 4 mm up to about 6 mm). It may have a diameter as described elsewhere herein so that it can be supported on. An IOL may be inserted into recess 2104 under sunshade 2126 . Thus, the diameter between the first and second opposing awnings 2126 is sufficient for IOL insertion. Since the IOL is typically collapsible, the diameter between the first and second sheaths 2126 can vary widely. In some implementations, opposing sunshades 2126 are fully connected to each other along sides 2108 (see FIG. 24C ). Opposite sunshade 2126 may include an extension along each side 2108 that forms a complete protruding surface over lens support structure 2105 defining top aperture 2127 . The upper aperture 2127 may have a larger diameter than the diameter of the central aperture 2115 of the lens support structure 2105 . For example, upper aperture 2127 can be larger than about 6 mm so that the IOL can be manipulated into place and fully unfolded into position with recess 2104. The diameter of the top hole 2127 can be greater than 6 mm up to about 8 mm.

27 shows an interrelated implementation of device 2100 having a sunshade 2126 that further incorporates a plurality of bumpers 2119 to aid in centering of device 2100 within the eye. Device 2100 may include four bumpers 2119 projecting outwardly from respective corners of lens support structure 2105 . The bumper 2119 may be substantially ring-shaped or may be an incomplete ring having a C-shape. Ring-shaped bumper 2119 can include a first end and a second end that are both coupled to lens support structure 2105 . The C-shaped bumper 2119 can have one end coupled to the lens support structure 2105 and a second end that remains separate from the lens support structure 2105 . Regardless of shape or configuration, bumper 2119 may urge device 2100 away from adjacent ocular tissue. In some implementations, bumper 2119 may deform slightly when in contact with the ciliary structure. The deformation may be temporary, such that the bumper returns to its original shape, urging the device 2100 back towards a centralized position within the eye. As with other implementations described herein, device 2100 may include a plurality of stationary arms 2120 including at least one biased in a folded configuration. Preferably, bumper 2119 prevents device 2100 from remaining in contact with the ciliary structure once implanted. The bumper 2119 can act as a guide during externalization of the fixation arm 2120 . The bumper 2119 can protrude far enough away from the outer periphery 2111 of the lens support structure 2105, so that it abuts against the ciliary body 15 and/or within the ciliary furrow 25 in the Z-plane. prevents displacement in and maintains proper alignment between the central aperture 2115 and the visual axis of the eye during fixation.

A needle or guide wire (with or without sutures) may be molded into the distal scaffold or anchor 125 so that the fixation arm 120 can be externalized from within the eye. An applicable needle or guide wire can be externalized at a precise location prior to inserting the body of device 100 into the eye. Once the surgeon is satisfied with the placement of the needle or guide wire, the device 100 can be inserted into the eye and each fixation arm 120 will be locked in place with appropriate procedures to ensure centering and z-axis positioning. can Once device 100 is properly secured, the surgeon may trim sutures and/or needles from device 100 leaving anchor 125 in place. Alternatively, modified sharp tip forceps/forceps can be inserted through the primary corneal wound (used for insertion of the lens fixation device) and subsequently used to engage fixation arm 120 and externalized. This allows a single pass to create the scleral incision and externalize the fixation arm anchor 125 .

Device 100 may be inserted through a corneal or scleral incision using forceps or other common ophthalmic instruments. Alternatively, device 100 may be implanted using an implanter system similar to an intraocular lens implanter. The injector causes the device 100 to unfold in a manner that sequentially presents the anchoring arm 120 to the surgeon. Alternatively, the implanter may present the entire device 100 in an anterior or posterior chamber in a configuration that limits the risk of surgical error. For example, an injector may ensure that device 100 is inserted “right side up”. Additionally, the injector may limit the risk of damaging the iris 10, endothelium, capsule, or frenulum during implantation.

The device 100 described herein provides a stable platform and serves as an artificial anterior aspect of the capsular bag for placement of the IOL 110 . Reliable centering and axial positioning of lens support structure 105 is important for optimal functioning of device 100 . In some implementations, the guide system can be used to align the scleral incision site. The guide system may employ features similar to intraoperative toric markers and preoperative toric bubble markers. In addition to marking the correct meridian location, markers can help align the incision relative to the limbus. Acceptable locations for scleral incision may include posterior to the limbus and anterior to the ora serota. In the human eye, the scleral incision may be placed approximately 0.1 mm to about 4 mm posterior to the limbus. By varying the anterior/posterior scleral incision site for the limbus from about 0.1 mm to about 4 mm (z axis) or from about 1.5 mm to about 4 mm, the fixation arm tension can be controlled within an acceptable range. Using marker/device pairs of various diameters, the optimal size and location of device 100 can be determined with the guide/marking system. 14A and 14B and 15A-15I are examples incorporating a plurality of marking features 1005 that may be used to aid in the identification and marking of scleral incision sites for insertion of anchoring arm 120 of device 100. An exemplary scleral incision guide tool 1000 is illustrated. Tool 1000 may incorporate three marking features 1005 protruding from distal end region 1015 of handle 1010 . The handle 1010 can extend along a first axis A and the distal end region 1015 can be angled away from the first axis A. The marking feature 1005 can protrude distally of the angled distal end region 1015 such that the feature 1005 is offset from the first axis A. The distal end region 1015 of the tool 1000 may form a tripod 1020 with a feature 1005 protruding from each prong 1025 of the tripod 1020 (see FIG. 14A ). The distal end region 1015 of the tool 1000 can include a ring 1030 and the marking feature 1005 protrudes from the distal opposing surface of the ring 1030 (see FIG. 14B ). Ring 1030 may provide a centering function. The surgeon may use limbal, pupillary, or white-to-white criteria. Marking feature 1005 may create at least three points of contact to define the location of the scleral incision. The contact points of tool 1000 provided by marking feature 1005 may correspond to the number of scleral incisions required for fixation of device 100 .

Each marking feature 10005 may protrude a distal distance as well as a distance outward from the ring 1030 (or tripod 1020). 15A-15D show an implementation of tool 1000 that incorporates a larger standoff from marking feature 1005 for ring 1030 compared to the embodiment shown in FIGS. 14A and 14B. Marking feature 1005 may have a length between the most distal tip 1035 and the starting point in ring 1030 providing a standoff of about 1 mm to about 10 mm or about 3 mm to about 6 mm. Tool 1000 avoids interaction with ophthalmic instruments such as speculums, trocars, or other instruments that may be on the surface of the eye during surgery. In some implementations, ring 1030 may further incorporate crosshairs 1040 for centering (see FIGS. 15H-15I ). The distance between the distal most tip 1035 of each marking feature 1005 and the ring 1030 stands high enough to prevent the ring 1030 (or crosshair 1040, if present) from contacting the cornea during use. Off (see FIGS. 15E-15G).

The inner diameter of ring 1030 may be from about 5 mm to about 15 mm (see FIG. 16A). The overall diameter defined by the distal-most tip 1035 of the tool 1000 may be between about 11 mm and about 18 mm, or between about 13 mm and about 17 mm (see FIG. 16B ). Marking features 1005 may be symmetrically distributed around the circumference of ring 1030 . For example, if there are three marking features 1005, each marking feature may be positioned about 120 degrees circumferentially from each other. Each marking feature 1005 may incorporate a bevel or double bevel leading to the distal most tip 1035 such that the distal most tip 1035 forms a generally sharp point suitable for marking the sclera, such as by creating an indentation. There is (see Figs. 16a to 16d). The bevel to create the point of the most distal tip 1035 may extend in length from about 0.15 mm to about 1.5 mm. The distal-most tip 1035 may slope inward toward the center of the ring 1030 such that the distal-most tip 1035 is offset from the outermost extent of the marking feature 1005 (see FIG. 16D ). The offset of the tip 1035 relative to the outermost extent of the marking feature 1005 can be a distance from the outermost extent that is between about 0.15 mm and about 1.5 mm. Each marking feature 1005 may have a length of about 3 mm to about 10 mm and the beveled portion leading to the distal most tip 1035 may be 0.15 mm to about 1.5 mm of this length. The tip 1035 need not be sharp to provide a marking function to the sclera. Tip 1035 is blunt and can still be used to mark the sclera as shown in FIGS. 14A and 14B . Whether blunt or sharp, tip 1035 may be used to mechanically mark the sclera by applying discrete visual markers to the sclera or creating multiple indentations. For example, the lower end of each tip 1035 can be used to deliver an amount of ink or other visually appropriate material that can be delivered from the tip 1035 to the sclera.

Externalization of the anchors 125 may be performed using standard tools used in ophthalmology. 17C-17D illustrate a snare device 200 for externalization of an anchor 125. As described elsewhere herein, the scaffold or anchor 125 is designed to be externalized through a scleral incision (eg, a 23, 25 or 27 gauge scleral incision). The snare device 200 may be designed to secure the transsclera by grasping and releasing the anchor 125 and/or anchoring arm 120 of the device. The snare device 200 can include an adjustable loop 205 configured to expand and contract in size. Loop 205 may pass through part or all of anchor 125 . The loop 205 can be tightened so that the opening of the loop 205 is reduced to securely engage the anchor and/or anchoring arm. The surgeon can externalize the anchor 125 while minimizing the risk of losing grip on the anchor 125 by using the device 200 with the minimized loop 205 surrounding the fixation arm/anchor. Upon externalization of the anchors 125, the loops 205 can be at least partially reopened to enlarge the open area of the loops 205 to release the anchors 125. In a fully or partially open configuration, the loop 205 may have an inner circumference of about 1.5 mm to about 10.0 mm. In a closed capture configuration, the inner circumference of the loop 205 may be between about 0.25 mm and about 2.5 mm. The snare device 200 may be designed such that the loop can atraumatically grip the anchor 125 and/or the anchoring arm 120 without damaging the device 100 . For example, the lasso device 200 cannot have sharp corners. The material of loop 205 may provide mechanical properties that allow loop 205 to atraumatically capture arm 120 and repeatedly transition from a large circumference configuration to a small circumference configuration and back again. The material of the loop 205 may provide a tight grip in a non-traumatic interaction with the anchor 120 or anchor 125 . While gripping the anchor 120 or anchor 125, the loop 205 may deform to a significant degree during the externalization process. At least a portion of the snare device 200 may be bent. For example, the snare device 200 can be manufactured to have a bend near the distal end region or to be manually bent by the user when in use to suit ergonomic needs.

The loop 205 may be a wire-like structure having an overall radius of curvature. The wire-like structure may be a rigid material such as stainless steel, titanium, nitinol or other metal. Alternatively, the wire-like structure may be composed of plastic such as polypropylene, polyethylene, nylon, Gore-Tex, polyimide, PMMA or other plastics. Alternatively, the wire-like structure of loop 205 may be made of an elastomeric material such as flexible acrylic, polyurethane, silicone, SIBS or other elastomeric polymers with similar mechanical properties.

The snare device 200 may also be configured to make a scleral incision and/or function as an IOL gripper. 18A-18D show an implementation of the lasso device 200 . A loop 205 or other snare feature may extend from an interior lumen of the device. The opening from the inner lumen may be at the distal end as shown in FIGS. 17C and 17D . The opening from the inner lumen may also be located proximal of the distal end through the sidewall of the device as shown in FIGS. 18A and 18B or a sharp tip may be inserted through the loop 205 as shown in FIGS. 18C and 18D . It may be swaged to extend distally of the orifice exiting the lumen. The device may have additional features to protect the snare material and device from being damaged by the sharp edges of the distal tip 210 . For example, the sharp distal tip 210 of the needle may be covered by a sheath or other element configured to have a lumen and extend beyond the distal tip 210 . This sheath can provide an atraumatic surface to which the loop 205 can be anchored. Alternatively, the puncture tip 210 may be positioned a distance from the opening 215 through which the loop 205 is actuated, for example about 0.2 mm to 10 mm from the opening 215 . Device 200 may incorporate a distal tip 210 suitable for making a scleral incision. The distal tip 210 may have a variety of geometries, such as a non-coring trocar tip as shown in FIGS. 18A and 18B or a posterior beveled needle cannula tip as shown in FIGS. 18C and 18D . The geometry of the distal tip 210 may include, but is not limited to, a bevel, three-sided trocar, conical, diamond, pencil point, swaged, skived, or other pointed geometry.

In another implementation, anchor 125 may be externalized using a forceps type device. Forceps may be straight or inclined. Forceps devices may incorporate locking features to improve the surgeon's grip. The forceps device for externalization may transition from locking to unlocking or vice versa through any of a variety of mechanical movements, including twisting, squeezing, sliding, mechanisms that reduce the range of motion of the forceps once engaged. In some implementations, the locking forceps have two gripping surfaces that are locked in a restricted form. In other implementations, the forceps have three or four gripping surfaces that can be locked into a restricted form. A locked or constrained form may also enclose the anchor 125 within an enclosure to aid in the externalization procedure. Fully enclosing the anchor 125 may limit interference between the anchor and the sclera when inserted through a wound. The sheath may define an outermost surface during externalization that may be designed to interact optimally with ocular tissue. For example, the outermost surface of the enclosure may have a round (eg, circular, oval, ovoid, etc.) profile. The sheath may also have a coating to reduce friction with tissue during externalization. The sheath may be sufficiently rigid to substantially retain its shape during externalization.

The devices described herein can be implanted in the posterior chamber of an eye that lacks an intact capsular bag. As described elsewhere herein, prior to insertion into the posterior chamber, at least one of the at least three anchoring arms may be biased toward a linear configuration and at least a second arm of the at least three anchoring arms may be in a folded configuration. may be biased towards The folded configuration is such that the anchor at the beginning, distal end portion of the fixing arm extending away from the lens support structure can be positioned above or below at least one of a portion of the lens support structure and a portion of the central opening; It includes the center part of the fixing arm which has an attachment or a curved part. When the device is inserted into the posterior chamber, at least a portion of the anchoring arm in a collapsed configuration can be visualized through the pupil. An anchor of the straight fixation arm may be gripped and externalized through and over the first portion of the sclera. An anchor of the curved fixation arm may be gripped, deployed and externalized through and over the second portion of the sclera. A third of the fixation arms can then be gripped, tensioned, and externalized through and over a third portion of the sclera to position and stabilize the device within the posterior chamber of the eye.

Appropriate materials or combinations of materials for fabrication of the various components of the devices disclosed herein are provided throughout. It should be understood that other suitable materials are contemplated. Device 100 may be constructed of any implant grade material capable of providing the necessary functionality for lens support structure 105 , anchor arm 120 , and anchor 125 . Materials that may be employed in this device may be silicone elastomer, fluorosilicone elastomer, polyurethane, hydrophilic or hydrophobic acrylic, polyolefin, nylon, PVDF, PMMA, polyimide, nitinol, titanium, stainless steel, or other implant grade materials. but not limited thereto. Devices can be made of a combination of materials that are geometrically matched together, chemically bonded or welded together, overmolded, encapsulated, or using other means to combine different materials. A given device element can be made of several materials. The anchoring arm 120 may be constructed from inelastic or semi-rigid materials common to ophthalmic applications such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic, or high hardness silicone. The anchoring arm 120 may incorporate or be formed of an elastic material such as acrylic, polyurethane, silicone elastomer or copolymers thereof that facilitates manipulation of the anchoring arm 120 during implantation. In another implementation, the anchoring arm 120 is a soft elastomeric material such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic, or acrylic, polyurethane, silicone elastomer or copolymers thereof. It may be formed of a semi-rigid or rigid plastic material such as embedded or coated high-hardness silicone.

In various implementations, the description is made with reference to the drawings. However, a particular implementation may be practiced without one or more of these specific details or in conjunction with other known methods and configurations. In the description, numerous specific details are set forth such as specific configurations, dimensions, and processes in order to provide a thorough understanding of the implementation. In other instances, well known processes and manufacturing techniques have not been described in particular detail in order not to unnecessarily obscure the description. References throughout this specification to “one embodiment”, “an embodiment”, “an implementation”, “an implementation”, etc., indicate that a particular feature, structure, configuration or characteristic described is included in at least one embodiment or implementation. it means. Thus, the appearances of the phrases “one embodiment,” “an embodiment,” “an implementation,” “an implementation,” and the like in various places throughout this specification are not necessarily all referring to the same embodiment or implementation. Moreover, certain features However, the structures, configurations, or characteristics may be combined in any suitable way in one or more implementations.

The devices and systems described herein may incorporate any of a variety of features. Elements or features of one implementation of the devices and systems described herein may alternatively or be incorporated in combination with elements or features of another implementation of the devices and systems described herein. For brevity, an explicit description of each combination may be omitted, even though various combinations are contemplated herein. Further, the devices and systems described herein may be placed within the eye and need not be specifically implanted as shown in the figures or as described herein. A variety of devices may be implanted, positioned and adjusted according to a variety of different methods and using a variety of different devices and systems. The various devices can be adjusted at any time before implantation, during implantation and after implantation. While several representative descriptions of how various devices may be implanted and positioned are provided, explicit descriptions of each method for each implant or system may be omitted for brevity.

Use of relative terms throughout the description may indicate relative positions or directions or orientations and is not intended to be limiting. For example, “far” may indicate a first direction away from a reference point. Similarly, "proximal" can refer to a location in a second direction opposite the first direction. Use of the terms "upper", "lower", "top", "lower", "anterior", "lateral" and "posterior" as well as "anterior", "posterior", "caudal", "cranial", etc. is used to establish a relative frame of reference and is not intended to limit the use or orientation of any of the devices described herein in various implementations.

Although this specification contains many details, they should not be construed as limitations on the scope claimed or what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments individually or in any suitable subcombination. Moreover, while features may be described above as acting in particular combinations, and may even be initially claimed as such, one or more features from a claimed combination may in some cases be removed from the combination, and the claimed combination may be a subcombination or subcombination. It may be about a variation of the combination. Similarly, while operations are shown in a particular order in the figures, it is understood that such operations are performed in the particular order shown or in a sequential order, or that all operations illustrated are required to be performed in order to achieve a desired result. It shouldn't be. Only a few examples and implementations are disclosed. Variations, modifications and improvements to implementations other than the described examples and implementations may be made based on what is disclosed.

In the above description and claims, phrases such as “at least one of” or “one or more of” may appear after a linked list of elements or features. The term "and/or" can also appear in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such phrases are not intended to mean any of the listed elements or features individually or any of the listed elements or features to any of the other listed elements or features. It is intended to mean in combination with For example, the phrases "at least one of A and B", "at least one of A and B" and "A and/or B" are intended to mean "A alone, B alone, or A and B together", respectively. . A similar interpretation is intended for lists containing three or more items. For example, "at least one of A, B and C"; "at least one of A, B and C"; and the phrases "A, B and/or C" are intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together", respectively. it is intended

The use of the term "based on" in the above description and claims is intended to mean "based at least in part on" such that features or elements not described may also be permitted.

Claims (140)

An implantable device for supporting an intraocular lens within an eye, comprising:
a support structure comprising an outer circumferential surface, a front facing surface, a rear facing surface, and a single central aperture extending through the entire thickness of the support structure between the front facing surface and the rear facing surface, the single aperture having a continuous inner circumference; and
a plurality of anchoring arms coupled to the support structure and configured to be placed in tension to position and stabilize the device within the eye, each of the plurality of anchoring arms having a distal end coupled to a transsclera anchor for sutureless scleral fixation; , device. The device of claim 1 , wherein the transscleral anchor is configured to be externalized atraumatically. 3. The device of claim 2, wherein the transsclera anchor is positionable outside the sclera and inside the conjunctiva. The device of claim 1 , wherein at least one of the plurality of anchoring arms is substantially non-planar. The device according to claim 1 , wherein the plurality of anchoring arms includes three anchoring arms extending outwardly from the outer circumferential surface of the support structure. 6. The device of claim 5, wherein at least a first of the three fixation arms is biased towards the center of the device. 7. The device of claim 6, wherein at least a first arm and a second arm of the three anchor arms are each biased toward the center of the device. 8. The device according to claim 7, wherein a third fixation arm of the three fixation arms has an increased cross-sectional area compared to the cross-sectional areas of the first and second fixation arms. 9. The device of claim 8, wherein the increased cross-sectional area of the third fixation arm increases its stiffness compared to the stiffness of the first or second fixation arm. 6. The device according to claim 5, wherein the three fixing arms are evenly distributed around the outer circumferential surface of the support structure. The device of claim 1 , wherein the anterior facing surface forms a stable platform on which the intraocular lens is placed during use. The device of claim 1 , wherein the continuous inner circumference defines a uniform substantially circular shape and the outer circumferential surface defines a substantially non-circular shape. 13. The device of claim 12, wherein in use, the support structure provides centering of the device without 360 degree contact with the ciliary body along a substantially non-circularly shaped outer circumferential surface. 13. The device of claim 12, wherein in use, the substantially non-circularly shaped outer circumferential surface of the support structure avoids contact with the ciliary body or contacts the ciliary body along less than 120 degrees. 13. The device of claim 12, wherein in use, the substantially non-circularly shaped outer circumferential surface of the support structure contacts the ciliary projections at three distinct points. The device of claim 1 , wherein the outer circumferential surface of the support structure comprises a plurality of lobes projecting outwardly from a plurality of substantially planar or concave sides. 17. The device of claim 16, wherein the plurality of lobes comprises three convex lobes that provide a substantially rounded triangular shape to the support structure. 18. The device of claim 17, wherein the three convex lobes provide an anti-rotation function in the Z-plane. 18. The device of claim 17, wherein in use, the three convex lobes provide non-invasive contact with the ciliary body. The device of claim 1 , wherein the support structure includes one or more slits formed in the inner wall defining a central aperture. The device of claim 1 , wherein the support structure has a thickness from the front facing surface to the rear facing surface that tapers toward the central hole. The device of claim 1 , wherein at least one of the plurality of anchoring arms comprises along its length a plurality of anchors comprising a transscleral anchor at a distal end. The device of claim 1 , wherein in use, the transscleral anchor is configured to be positioned outside the sclera. 24. The device of claim 23, wherein the transscleral anchor comprises a geometry configured to pass through the sclera in a first direction during insertion and resist pulling through the sclera in a second, opposite direction. 24. The method of claim 23, wherein when at rest, at least one of the plurality of fixation arms incorporates a bend between its origin with the support structure and its distal end coupled to a transscleral anchor forming a bent fixation arm. device. 26. The device of claim 25, wherein the bend is between 90 and 270 degrees from the starting point in the radial and centripetal directions. 26. The device of claim 25, wherein the bend is 180 degrees from a starting point with the support structure. 26. The device of claim 25, wherein when at rest, the distal end of the bent fixation arm lies in a different plane than the plane of the support structure, and the transsclera anchor is positioned over at least a portion of the support structure. 29. The device of claim 28, wherein the bent fixation arm incorporates a resilient material or a deformable hinge to facilitate unfolding of the bent fixation arm such that the distal end approaches the plane of the support structure. 26. The device of claim 25, wherein the two fixation arms are flexible and have an inward deflection and the third fixation arm is less flexible than the two fixation arms. The device of claim 1 , wherein the transscleral anchor of each of the plurality of fixation arms is configured to be positioned outside the sclera. 32. The device of claim 31, wherein the transscleral anchor comprises a central portion and one or more peripheral grippable portions, the central portion arranged such that the anchor overlies a wound to be externalized upon implantation. 33. The device of claim 32, wherein the central portion has an increased thickness, height, and/or width compared to the grippable portion. The device of claim 1 , wherein one of the plurality of anchoring arms is mechanically braced. 35. The device of claim 34, wherein the mechanical reinforcement biases the device anteriorly upon implantation. A method comprising implanting an anterior capsule device having an artificial frenulum fixation that provides a stable platform for placement of an intraocular lens within an artificially constructed sulcus. An implantable device for supporting an intraocular lens within an eye, comprising:
A support structure lying substantially in a first plane, the support structure comprising a perimeter surface, a front facing surface, a rear facing surface, and a single central hole extending through the entire thickness of the support structure between the front facing surface and the rear facing surface; , a support structure in which a single hole has a continuous inner circumference; and
three anchoring arms coupled to the support structure and configured to position and stabilize the device within the eye, each of the three anchoring arms having a distal end coupled to the transsclera anchor for sutureless scleral fixation;
When at rest, at least a first of the three fixed arms incorporates a bend between its starting point with the supporting structure and its distal end forming the first bent arm, the distal end of the first bent arm. lies in a second plane different from the first plane. 38. The device of claim 37, wherein the transscleral anchor of the first bent arm is positioned over at least a portion of the support structure. 38. The device of claim 37, wherein the transscleral anchor of the bent arm is positioned over at least a portion of the central aperture. 38. The method of claim 37, wherein at least a second of the three fixed arms incorporates a bend between its starting point with the support structure and its distal end forming the second bent arm, the distal end of the second bent arm. lies in a second plane different from the first plane. 41. The device of claim 40, wherein the transscleral anchor of the second bent arm is positioned over at least a portion of the support structure. 41. The device of claim 40, wherein the transscleral anchor of the second bent arm is positioned over at least a portion of the central aperture. 41. The method of claim 40, wherein the third fixed arm of the three fixed arms is straight between its starting point with the support structure and its distal end forming a straight fixed arm, and the straight fixed arm is shorter than the first and second bent arms. Less flexible adults, devices. 44. The device of claim 43, wherein the first and second bent arms are biased towards a central axis of the device. An implantable device for supporting an intraocular lens within an eye, comprising:
A support structure lying substantially in a first plane, the support structure comprising a perimeter surface, a front facing surface, a rear facing surface, and a single central hole extending through the entire thickness of the support structure between the front facing surface and the rear facing surface; , a support structure, wherein the single hole has an inner circumferential surface with a circumference; and
and three fixation arms coupled to the support structure and configured to be placed in tension to position and stabilize the device within the eye, each of the three fixation arms having a distal end coupled to a transscleral anchor for sutureless scleral fixation. ,
wherein the inner circumferential surface forms a uniform substantially circular shape and the outer circumferential surface forms a substantially non-circular shape. 46. The device of claim 45, wherein the non-circular shape of the outer peripheral surface comprises a plurality of lobes projecting outwardly from a plurality of sides. 47. The device of claim 46, wherein the plurality of sides are substantially flat or concave. 47. The device of claim 46, wherein each of the three anchoring arms extends outwardly from a respective side of the plurality of sides. 46. The device of claim 45, wherein the support structure has a width between an outer circumferential surface and an inner circumferential surface that varies around the circumference. 47. The device of claim 46, wherein each of the three fixation arms has a length greater than the distance at which the plurality of lobes protrude outward. 46. The device of claim 45, wherein the front facing surface and the back facing surface of the support structure taper toward a central axis of the device. 46. The device of claim 45, wherein the inner and outer surfaces are convex such that the inner surface projects toward a central axis of the device and the outer surface projects away from the central axis of the device. 46. The device of claim 45, wherein the thickness of the support structure from the front facing surface to the back facing surface is from about 0.15 mm to about 1.5 mm. 46. The device of claim 45, wherein the support structure is substantially planar. 46. The device of claim 45, wherein the support structure incorporates a recess in the front facing surface. 46. The device of claim 45, wherein the support structure incorporates one or more posts projecting upwardly from the front facing surface. A device for implantation into the posterior chamber of an intact capsular bag-free eye,
A support structure comprising a central aperture, the support structure configured to provide support for an artificial intraocular lens, wherein after implantation into the eye, the device and the artificial intraocular lens are configured to allow light to pass through both the aperture and the artificial intraocular lens. which is, the support structure;
at least three anchoring arms extending substantially orthogonally from the support structure, prior to implantation, one of the at least three anchoring arms extends from the support structure in a deployed configuration, and at least two of the at least three anchoring arms extend from the support structure extends from into the folded configuration, one of the at least three anchoring arms biasing towards the unfolded configuration and at least two of the at least three anchoring arms biasing towards the collapsed configuration prior to implantation;
Upon implantation, each of at least two of the at least three anchoring arms are deployed, and each of the at least three anchoring arms comprises an atraumatic distal anchor portion for sutureless transscleral fixation of the device within the posterior chamber. A device for implantation into the posterior chamber of an intact capsular bag-free eye,
a support structure comprising a central aperture extending through the entire thickness of the support structure; and
a plurality of fixation arms, each of the plurality of fixation arms including a proximal portion in a support structure and a distal end portion coupled to an atraumatic anchor for sutureless transscleral fixation;
Prior to transscleral fixation of the anchor, the plurality of fixation arms comprises curved fixation arms curved between their proximal and distal ends enabling visualization of at least a portion of the curved fixation arms through the pupil of the eye. . 59. The device of claim 58, wherein after anchoring the transsclera, each of the plurality of anchoring arms is tensioned between the proximal and distal ends to align the support structure with respect to the Z-plane of the eye. 60. The device of claim 59, wherein the support structure is configured to provide support for an intraocular lens and the central aperture is configured to allow passage of light through both the central aperture and the intraocular lens supported by the support structure. 59. The device of claim 58, wherein the curved fixation arm is bent forward and the atraumatic anchor is positioned over at least a portion of the support structure. 59. The device of claim 58, wherein the curved fixation arm is bent backwards and the atraumatic anchor is positioned under at least a portion of the support structure. A method of implanting a device into the posterior chamber of an eye without an intact capsular bag,
Inserting the device into the posterior chamber, wherein the device:
a lens support structure having a central opening;
comprising at least three fixing arms, each of the at least three fixing arms having a start portion coupled to the lens support structure and a distal portion including an anchor;
Prior to insertion into the posterior chamber, at least one of the at least three anchoring arms is biased towards a linear configuration and at least a second arm of the at least three anchoring arms is biased towards a folded configuration, wherein the collapsed configuration comprises:
a beginning portion extending away from the lens support structure;
a central portion comprising bends, folds or bends; and
an anchor of a distal portion positioned above or below at least one of a portion of the lens support structure and a portion of the central aperture;
gripping an anchor of at least one of the at least three fixation arms and externalizing the anchor through and over a first portion of the sclera;
gripping the anchor of the second fixation arm, unfolding the folded configuration of the second fixation arm, and externalizing the anchor of the second fixation arm through and over the second portion of the sclera; and
A device within the posterior chamber of the eye by gripping an anchor of a third fixation arm of the at least three fixation arms, tensioning the third fixation arm and externalizing the anchor of the third fixation arm through and over a third portion of the sclera. positioning and stabilizing. A device for holding an artificial intraocular lens in an eye,
a lens support structure comprising a central aperture, through which light can be directed towards the retina when the device is implanted into the eye; and
including at least three fixing arms, each of the at least three fixing arms including a start portion coupled to the lens support structure and extending outwardly from the lens support structure and a distal portion including an anchor for fixing the device in the eyeball to the scleral membrane; and;
Prior to implantation, at least one fixation arm of the at least three fixation arms is biased toward a folded configuration incorporating a bend between the proximal and distal portions that positions the anchor of the distal portion to overlap at least a portion of the lens support structure. , device. 65. The device of claim 64, wherein the anchor of the at least one fixation arm in the folded configuration is positioned over at least a portion of the lens support structure and forward of the lens support structure relative to the retina when positioned within the eye and prior to scleral fixation. . 66. The device of claim 65, wherein the anchor positioned over at least a portion of the lens support structure is over and in front of the central aperture of the lens support structure to the retina. 66. The device of claim 65, wherein at least a first portion of the anchor is above and in front of the central aperture and at least a second portion of the anchor is above and in front of the lens support structure to the retina. 65. The method of claim 64, wherein the anchor of the at least one fixation arm in the folded configuration is positioned under at least a portion of the lens support structure and posterior to the lens support structure relative to the retina when positioned within the eye and prior to scleral fixation. device. 69. The device of claim 68, wherein the anchor located under at least a portion of the lens support structure is below and posterior of the central opening of the lens support structure to the retina. 69. The device of claim 68, wherein at least a first portion of the anchor is below and posterior of the central aperture and at least a second portion of the anchor is below and posterior of the lens support structure to the retina. 65. The device of claim 64, wherein the folded configuration comprises a distal portion folded above or below a beginning portion of the at least one anchoring arm. 65. The device of claim 64, wherein in the folded configuration the distal portion of the at least one anchoring arm overlaps the beginning portion. 65. The device of claim 64, wherein the anchors of the distal portion of the at least one fixation arm in the folded configuration are visible through the pupil of the eye upon placement of the device in the posterior chamber of the eye but prior to fixation of the anchor to the scleral membrane. 65. The device of claim 64, wherein the anchor of the at least one fixation arm in the folded configuration is located within a distance from a central axis of the device, the central axis extending anteriorly-rearwardly through the central opening, and wherein the distance is no greater than about 4.0 mm. 65. The device of claim 64, wherein in the folded configuration the at least one anchoring arm is curved such that an anchor of a distal portion of the at least one anchoring arm protrudes back toward the central opening of the device. 65. The device of claim 64, wherein the anchor is configured for sutureless transsclera fixation. 65. The device of claim 64, wherein the lens support structure is generally ring shaped. 65. The device of claim 64, wherein the lens support structure further comprises an outer periphery and an inner periphery, wherein the central opening is defined by the inner periphery, the outer periphery of the lens support structure is substantially non-circular, and the inner periphery is substantially circular. 65. The device of claim 64, wherein the lens support structure comprises a perimeter, the perimeter comprising a plurality of lobes projecting radially away from the central aperture. 80. The device of claim 79, wherein a first numerical count of the plurality of lobes is equal to a second numerical count of the at least three fixation arms, each lobe being spaced between adjacent fixation arms. 81. The method of claim 80, wherein each lobe is symmetrically spaced around the circumference of the lens support structure between adjacent fixation arms, and each of the at least three fixation arms is symmetrically spaced around the circumference of the lens support structure between adjacent lobes. device. 81. The device of claim 80, wherein the plurality of lobes consists of three lobes, and wherein the at least three fixation arms consist of three fixation arms. 80. The device of claim 79, wherein the plurality of lobes comprises at least three convex lobes that provide a substantially rounded triangular shape to the lens support structure. 84. The device of claim 83, wherein when implanted, the at least three convex lobes provide non-invasive contact with the ciliary tissue of the eye. 65. The device of claim 64, wherein at least two of the at least three anchoring arms are biased towards the folded configuration prior to implantation. 65. The device of claim 64, wherein all of the at least three anchoring arms are biased towards the folded configuration prior to implantation. 65. The device of claim 64, wherein at least a second of the at least three anchoring arms is biased toward the deployed configuration prior to implantation. 88. The method of claim 87, wherein the at least second fixation arm has a larger cross-sectional area compared to the cross-sectional area of at least one of the at least three fixation arms, so that the stiffness of at least one of the at least three fixation arms is at least greater. 2 A device providing increased rigidity of the fixation arm. 65. The device of claim 64, wherein the lens support structure comprises a substantially planar surface. 65. The device of claim 64, wherein the lens support structure comprises a geometry configured to mate with a periphery of an intraocular lens or one or more haptics of an intraocular lens. 91. The device of claim 90, wherein the geometry comprises a concavity, recess, channel or groove forming at least a portion of the inner circumference of the lens support structure. 65. The device of claim 64, wherein at least one fixation arm of the at least three fixation arms comprises a deformable material that facilitates unfolding of the fixation arm from a folded configuration to an unfolded configuration to facilitate fixation of the transsclera. 65. The device of claim 64, wherein after anchoring the transsclera, the at least one anchoring arm is tensioned between the proximal and distal ends in a stretched configuration to align the lens support structure with respect to the Z-plane of the eye. 65. The device of claim 64, wherein the device includes three fixation arms, two of the three fixation arms are flexible and biased towards the folded configuration, and the third fixation arm is more flexible than two of the three fixation arms. A device that is less flexible and biases toward a stretched out configuration. 95. The device of claim 94, wherein all three anchoring arms are configured to be placed in tension. 95. The device of claim 94, wherein each folded configuration of two of the three anchoring arms biases the distal portion toward a central axis of the device. 65. The device of claim 64, wherein the lens support structure is biased toward a substantially flat or planar configuration while at least one of the at least three anchor arms is biased toward a folded configuration. A device for holding an artificial intraocular lens in an eye,
a lens support structure comprising an inner circumferential surface that at least partially defines a central aperture, wherein light can be directed through the central aperture towards the retina when the device is implanted into the eye; and
comprising at least three fixing arms, each of the at least three fixing arms including a start portion coupled to the lens support structure and a distal portion including an anchor for fixing the device to the scleral membrane in the eye;
Prior to implantation, at least one fixation arm of the at least three fixation arms is biased towards the folded configuration; The folded configuration includes a start portion extending away from the lens support structure and an anchor of a distal portion positioned above or below at least one of a portion of the lens support structure and a portion of the central opening, and a bend between the start portion and the distal portion. Including, device. 99. The device of claim 98, wherein the anchor of the at least one fixation arm in the folded configuration is positioned over and anterior to the portion of the lens support structure to the retina when positioned within the eye and prior to sclera fixation. 99. The device of claim 98, wherein the anchors of the at least one fixation arm in the folded configuration are positioned over and anterior to a portion of the central opening to the retina when positioned within the eye and prior to scleral fixation. 99. The device of claim 98, wherein at least a first portion of the anchor is over and in front of a portion of the central aperture and at least a second portion of the anchor is over and in front of a portion of the lens support structure to the retina. 99. The device of claim 98, wherein the anchors of the at least one fixation arm in the folded configuration are positioned below and posterior to the portion of the lens support structure to the retina when positioned within the eye and prior to sclera fixation. 99. The device of claim 98, wherein the anchors of the at least one fixation arm in the folded configuration are positioned below and posterior to a portion of the central opening to the retina when positioned within the eye and prior to scleral fixation. 99. The device of claim 98, wherein at least a first portion of the anchor is below and posterior to a portion of the central aperture and at least a second portion of the anchor is below and posterior to a portion of the lens support structure to the retina. . 99. The device of claim 98, wherein the folded configuration comprises a distal portion folded above or below a beginning portion of the at least one anchoring arm. 99. The device of claim 98, wherein in the folded configuration the distal portion of the at least one anchoring arm overlaps the beginning portion. 99. The device of claim 98, wherein the anchors of the distal portion of the at least one fixation arm in the folded configuration are visible through the pupil of the eye upon placement of the device in the posterior chamber of the eye but prior to fixation of the anchor to the dura. 99. The device of claim 98, wherein the anchors of the at least one fixation arm in the folded configuration are located within a distance from a central axis of the device, the central axis extending anteriorly-rearwardly through the central opening, and wherein the distance is no greater than about 4.0 mm. 99. The device of claim 98, wherein in the folded configuration the at least one anchoring arm is curved such that an anchor of a distal portion of the at least one anchoring arm protrudes back toward the central opening of the device. 99. The device of claim 98, wherein the anchor is configured for sutureless transsclera fixation. 99. The device of claim 98, wherein the lens support structure is generally ring shaped. 99. The device of claim 98, wherein the lens support structure further comprises an outer perimeter, wherein the outer perimeter of the lens support structure is substantially non-circular and the inner perimeter is substantially circular. 99. The device of claim 98, wherein the lens support structure further comprises a perimeter, the perimeter comprising a plurality of lobes projecting radially away from the central opening. 114. The device of claim 113, wherein a first numerical count of the plurality of lobes is equal to a second numerical count of the at least three fixation arms, each lobe being spaced between adjacent fixation arms. 115. The method of claim 114, wherein each lobe is symmetrically spaced around the circumference of the lens support structure between adjacent fixation arms, and each of the at least three fixation arms is symmetrically spaced around the circumference of the lens support structure between adjacent lobes. device. 115. The device of claim 114, wherein the plurality of lobes consists of three lobes, and wherein the at least three fixation arms consist of three fixation arms. 114. The device of claim 113, wherein the plurality of lobes comprises at least three convex lobes that provide a substantially rounded triangular shape to the lens support structure. 118. The device of claim 117, wherein when implanted, the at least three convex lobes provide non-invasive contact with the ciliary tissue of the eye. 99. The device of claim 98, wherein at least two of the at least three anchoring arms are biased towards the folded configuration prior to implantation. 99. The device of claim 98, wherein all of the at least three anchoring arms are biased towards the folded configuration prior to implantation. 99. The device of claim 98, wherein at least a second of the at least three anchoring arms is biased toward the deployed configuration prior to implantation. 122. The method of claim 121, wherein the at least second fixation arm has a larger cross-sectional area compared to the cross-sectional area of at least one of the at least three fixation arms, thereby reducing the stiffness of at least one of the at least three fixation arms. 2 A device providing increased rigidity of the fixation arm. 99. The device of claim 98, wherein the lens support structure comprises a substantially planar surface. 99. The device of claim 98, wherein the lens support structure comprises a geometry configured to mate with a periphery of an intraocular lens or one or more haptics of an intraocular lens. 125. The device of claim 124, wherein the geometry comprises a concavity, recess, channel or groove forming at least a portion of the inner circumference of the lens support structure. 99. The device of claim 98, wherein at least one fixation arm of the at least three fixation arms comprises a deformable material that facilitates unfolding of the fixation arm from a folded configuration to an unfolded configuration to facilitate fixation of the transsclera. 99. The device of claim 98, wherein after anchoring the transsclera, the at least one anchoring arm is tensioned between the proximal and distal ends in a stretched configuration to align the lens support structure with respect to the Z-plane of the eye. 99. The device of claim 98, wherein the device includes three fixation arms, two of the three fixation arms are flexible and biased towards the folded configuration, and the third fixation arm is more flexible than two of the three fixation arms. A device that is less flexible and biases toward a stretched out configuration. 129. The device of claim 128, wherein all three fixation arms are configured to be placed in tension. 129. The device of claim 128, wherein each folded configuration of two of the three fixation arms biases the distal portion towards a central axis of the device. 99. The device of claim 98, wherein the lens support structure is biased toward a substantially flat or planar configuration while at least one of the at least three anchor arms is biased toward a folded configuration. 46. The device of claim 45, further comprising one or more sunshades positioned over the front facing surface of the support structure defining one or more recesses in front of the front facing surface. 133. The device of claim 132, wherein the one or more recesses are sized to receive at least a portion of an intraocular lens. 133. The device of claim 132, wherein the one or more shades have a smooth geometry configured to protect the iris of the eye from an edge of an intraocular lens. 133. The device of claim 132, wherein the one or more shades comprises a central opposing surface configured to provide counter pressure to the haptics of the intraocular lens. 133. The device of claim 132, wherein the substantially non-circular shape comprises a plurality of lobes and is triangular, oval, or rectangular. 133. The device of claim 132, wherein the substantially non-circular shape includes a plurality of lobes and is rectangular and the outer peripheral surface defines a pair of short sides and a pair of long sides. 138. The method of claim 137, wherein the one or more shades include first and second shades projecting over the anteriorly facing surface near the pair of short sides, the intraocular lens comprising an integral intraocular lens with a pair of haptics, wherein the first and second shades accommodate a span of haptics between the first and second shades. 139. The device of claim 138, wherein the first and second shades are connected to each other along the pair of elongated sides by an extension to define an upper aperture. 140. The device of claim 139, wherein the top hole has a diameter and the center hole has a diameter, the diameter of the top hole being greater than the diameter of the center hole of the support structure.

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